Trial Outcomes & Findings for Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine (NCT NCT02809833)

Last Updated: 2016-10-24

Results Overview

SmPC recommendations were specified in the collection of routine laboratory samples for alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), absolute neutrophil count (ANC), and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific upper limit of normal (ULN). Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10\^9 cells per liter (cells/L) for ANC and 50 to 100 × 10\^3 cells per microliter (cells/μL) for platelet count. The percentage of participants with greater than or equal to (≥) 1 documented/evaluable laboratory value at Baseline was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.

Recruitment status

COMPLETED

Target enrollment

850 participants

Primary outcome timeframe

Baseline

Results posted on

2016-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Tocilizumab for Rheumatoid Arthritis (RA) in Routine Practice Participants from routine clinical practice in Germany who received tocilizumab for RA according to the Summary of Product Characteristics (SmPC) were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion at 4-week intervals.
Overall Study STARTED	850
Overall Study COMPLETED	550
Overall Study NOT COMPLETED	300

Reasons for withdrawal

Reasons for withdrawal
Measure	Tocilizumab for Rheumatoid Arthritis (RA) in Routine Practice Participants from routine clinical practice in Germany who received tocilizumab for RA according to the Summary of Product Characteristics (SmPC) were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion at 4-week intervals.
Overall Study Death	3
Overall Study Intolerance	54
Overall Study Lack of Efficacy	89
Overall Study Remission/Treatment No Longer Needed	3
Overall Study Noncompliance	1
Overall Study Withdrawal by Subject	34
Overall Study Lost to Follow-up	35
Overall Study Adverse Event (AE)	24
Overall Study Other	5
Overall Study Missing Information	52

Baseline Characteristics

Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tocilizumab for RA in Routine Practice n=850 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Age, Continuous	55.9 years STANDARD_DEVIATION 12.9 • n=93 Participants
Sex: Female, Male Female	640 Participants n=93 Participants
Sex: Female, Male Male	210 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All Enrolled Population.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=850 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With Categorized Laboratory Data Available at Baseline ≥1 Documented/Evaluable Laboratory Value	98.6 percentage of participants
Percentage of Participants With Categorized Laboratory Data Available at Baseline ASAT Categorized	49.2 percentage of participants
Percentage of Participants With Categorized Laboratory Data Available at Baseline ALAT Categorized	63.5 percentage of participants
Percentage of Participants With Categorized Laboratory Data Available at Baseline ANC Categorized	7.3 percentage of participants
Percentage of Participants With Categorized Laboratory Data Available at Baseline Platelet Count Categorized	82.9 percentage of participants

PRIMARY outcome

Timeframe: Week 24

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10\^9 cells/L for ANC and 50 to 100 × 10\^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 24 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=598 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With Categorized Laboratory Data Available at Week 24 ≥1 Documented/Evaluable Laboratory Value	87.6 percentage of participants
Percentage of Participants With Categorized Laboratory Data Available at Week 24 ASAT Categorized	31.6 percentage of participants
Percentage of Participants With Categorized Laboratory Data Available at Week 24 ALAT Categorized	42.6 percentage of participants
Percentage of Participants With Categorized Laboratory Data Available at Week 24 ANC Categorized	4.2 percentage of participants
Percentage of Participants With Categorized Laboratory Data Available at Week 24 Platelet Count Categorized	58.9 percentage of participants

PRIMARY outcome

Timeframe: Week 52

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10\^9 cells/L for ANC and 50 to 100 × 10\^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 52 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=551 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With Categorized Laboratory Data Available at Week 52 Platelet Count Categorized	60.1 percentage of participants
Percentage of Participants With Categorized Laboratory Data Available at Week 52 ≥1 Documented/Evaluable Laboratory Value	86.4 percentage of participants
Percentage of Participants With Categorized Laboratory Data Available at Week 52 ASAT Categorized	29.0 percentage of participants
Percentage of Participants With Categorized Laboratory Data Available at Week 52 ALAT Categorized	39.9 percentage of participants
Percentage of Participants With Categorized Laboratory Data Available at Week 52 ANC Categorized	5.6 percentage of participants

PRIMARY outcome

Timeframe: Week 4

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values greater than (\>) 1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC less than (\<) 0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 4.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=701 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ALAT: >3 to 5 × ULN, Interruption: No (n=371)	1.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=283)	0.7 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ASAT: >1 to 3 × ULN, Adjustment: No (n=283)	14.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ASAT: >1 to 3 × ULN, Interruption: Yes (n=283)	0.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ASAT: >1 to 3 × ULN, Interruption: No (n=283)	14.8 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=283)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ASAT: >3 to 5 × ULN, Adjustment: No (n=283)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ASAT: >3 to 5 × ULN, Interruption: Yes (n=283)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ASAT: >3 to 5 × ULN, Interruption: No (n=283)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ASAT: >5 × ULN, Adjustment: Yes (n=283)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ASAT: >5 × ULN, Adjustment: No (n=283)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ASAT: >5 × ULN, Interruption: Yes (n=283)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ASAT: >5 × ULN, Interruption: No (n=283)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=371)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ALAT: >1 to 3 × ULN, Adjustment: No (n=371)	23.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ALAT: >1 to 3 × ULN, Interruption: Yes (n=371)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ALAT: >1 to 3 × ULN, Interruption: No (n=371)	23.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=371)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ALAT: >3 to 5 × ULN, Adjustment: No (n=371)	1.1 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ALAT: >3 to 5 × ULN, Interruption: Yes (n=371)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ALAT: >5 × ULN, Adjustment: Yes (n=371)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ALAT: >5 × ULN, Adjustment: No (n=371)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ALAT: >5 × ULN, Interruption: Yes (n=371)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ALAT: >5 × ULN, Interruption: No (n=371)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ANC: <0.5, Adjustment: Yes (n=46)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ANC: <0.5, Adjustment: No (n=46)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ANC: <0.5, Interruption: Yes (n=46)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ANC: <0.5, Interruption: No (n=46)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ANC: 0.5 to 1, Adjustment: Yes (n=46)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ANC: 0.5 to 1, Adjustment: No (n=46)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ANC: 0.5 to 1, Interruption: Yes (n=46)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 ANC: 0.5 to 1, Interruption: No (n=46)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 Platelets: <50, Adjustment: Yes (n=481)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 Platelets: <50, Adjustment: No (n=481)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 Platelets: <50, Interruption: Yes (n=481)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 Platelets: <50, Interruption: No (n=481)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 Platelets: 50 to 100, Adjustment: Yes (n=481)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 Platelets: 50 to 100, Adjustment: No (n=481)	0.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 Platelets: 50 to 100, Interruption: Yes (n=481)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 Platelets: 50 to 100, Interruption: No (n=481)	0.2 percentage of participants

PRIMARY outcome

Timeframe: Week 8

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 8.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=629 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 Platelets: <50, Interruption: Yes (n=443)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 Platelets: <50, Interruption: No (n=443)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 Platelets: 50 to 100, Adjustment: Yes (n=442)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 Platelets: 50 to 100, Adjustment: No (n=442)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 Platelets: 50 to 100, Interruption: Yes (n=443)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 Platelets: 50 to 100, Interruption: No (n=443)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=242)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ASAT: >1 to 3 × ULN, Adjustment: No (n=242)	13.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ASAT: >1 to 3 × ULN, Interruption: Yes (n=243)	0.8 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ASAT: >1 to 3 × ULN, Interruption: No (n=243)	11.9 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=242)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ASAT: >3 to 5 × ULN, Adjustment: No (n=242)	0.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ASAT: >3 to 5 × ULN, Interruption: Yes (n=243)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ASAT: >3 to 5 × ULN, Interruption: No (n=243)	0.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ASAT: >5 × ULN, Adjustment: Yes (n=242)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ASAT: >5 × ULN, Adjustment: No (n=242)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ASAT: >5 × ULN, Interruption: Yes (n=243)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ASAT: >5 × ULN, Interruption: No (n=243)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=329)	0.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ALAT: >1 to 3 × ULN, Adjustment: No (n=329)	26.1 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ALAT: >1 to 3 × ULN, Interruption: Yes (n=330)	1.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ALAT: >1 to 3 × ULN, Interruption: No (n=330)	25.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=329)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ALAT: >3 to 5 × ULN, Adjustment: No (n=329)	1.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ALAT: >3 to 5 × ULN, Interruption: Yes (n=330)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ALAT: >3 to 5 × ULN, Interruption: No (n=330)	1.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ALAT: >5 × ULN, Adjustment: Yes (n=329)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ALAT: >5 × ULN, Adjustment: No (n=329)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ALAT: >5 × ULN, Interruption: Yes (n=330)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ALAT: >5 × ULN, Interruption: No (n=330)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ANC: <0.5, Adjustment: Yes (n=41)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ANC: <0.5, Adjustment: No (n=41)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ANC: <0.5, Interruption: Yes (n=41)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ANC: <0.5, Interruption: No (n=41)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ANC: 0.5 to 1, Adjustment: Yes (n=41)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ANC: 0.5 to 1, Adjustment: No (n=41)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ANC: 0.5 to 1, Interruption: Yes (n=41)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 ANC: 0.5 to 1, Interruption: No (n=41)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 Platelets: <50, Adjustment: Yes (n=442)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 Platelets: <50, Adjustment: No (n=442)	0.0 percentage of participants

PRIMARY outcome

Timeframe: Week 12

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 12.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=574 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ASAT: >5 × ULN, Adjustment: Yes (n=229)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ALAT: >1 to 3 × ULN, Interruption: Yes (n=301)	1.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=300)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ALAT: >5 × ULN, Interruption: Yes (n=301)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ANC: <0.5, Adjustment: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 Platelets: 50 to 100, Adjustment: No (n=410)	0.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 Platelets: 50 to 100, Interruption: Yes (n=411)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=229)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 Platelets: <50, Adjustment: No (n=410)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 Platelets: <50, Interruption: Yes (n=411)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ASAT: >1 to 3 × ULN, Adjustment: No (n=229)	18.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ASAT: >1 to 3 × ULN, Interruption: Yes (n=230)	1.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ASAT: >1 to 3 × ULN, Interruption: No (n=230)	16.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=229)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ASAT: >3 to 5 × ULN, Adjustment: No (n=229)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ASAT: >3 to 5 × ULN, Interruption: Yes (n=230)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ASAT: >3 to 5 × ULN, Interruption: No (n=230)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ASAT: >5 × ULN, Adjustment: No (n=229)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ASAT: >5 × ULN, Interruption: Yes (n=230)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ASAT: >5 × ULN, Interruption: No (n=230)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=300)	1.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ALAT: >1 to 3 × ULN, Adjustment: No (n=300)	23.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ALAT: >1 to 3 × ULN, Interruption: No (n=301)	22.9 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ALAT: >3 to 5 × ULN, Adjustment: No (n=300)	1.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ALAT: >3 to 5 × ULN, Interruption: Yes (n=301)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ALAT: >3 to 5 × ULN, Interruption: No (n=301)	1.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ALAT: >5 × ULN, Adjustment: Yes (n=300)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ALAT: >5 × ULN, Adjustment: No (n=300)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ALAT: >5 × ULN, Interruption: No (n=301)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ANC: <0.5, Adjustment: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ANC: <0.5, Interruption: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ANC: <0.5, Interruption: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ANC: 0.5 to 1, Adjustment: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ANC: 0.5 to 1, Adjustment: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ANC: 0.5 to 1, Interruption: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 ANC: 0.5 to 1, Interruption: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 Platelets: <50, Adjustment: Yes (n=410)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 Platelets: <50, Interruption: No (n=411)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 Platelets: 50 to 100, Adjustment: Yes (n=410)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 Platelets: 50 to 100, Interruption: No (n=411)	0.2 percentage of participants

PRIMARY outcome

Timeframe: Week 16

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 16.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=545 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ASAT: >1 to 3 × ULN, Interruption: No (n=214)	16.8 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ASAT: >5 × ULN, Adjustment: No (n=214)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=282)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ALAT: >3 to 5 × ULN, Adjustment: No (n=282)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ALAT: >3 to 5 × ULN, Interruption: Yes (n=282)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ALAT: >3 to 5 × ULN, Interruption: No (n=282)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ALAT: >5 × ULN, Adjustment: Yes (n=282)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ALAT: >5 × ULN, Adjustment: No (n=282)	0.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ANC: <0.5, Adjustment: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ANC: <0.5, Interruption: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ANC: <0.5, Interruption: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ANC: 0.5 to 1, Adjustment: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ANC: 0.5 to 1, Adjustment: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 Platelets: <50, Adjustment: Yes (n=378)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 Platelets: <50, Adjustment: No (n=378)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 Platelets: <50, Interruption: No (n=378)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 Platelets: 50 to 100, Adjustment: Yes (n=378)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 Platelets: 50 to 100, Interruption: Yes (n=378)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 Platelets: 50 to 100, Interruption: No (n=378)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=214)	0.9 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ASAT: >1 to 3 × ULN, Adjustment: No (n=214)	16.8 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ASAT: >1 to 3 × ULN, Interruption: Yes (n=214)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=214)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ASAT: >3 to 5 × ULN, Adjustment: No (n=214)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ASAT: >3 to 5 × ULN, Interruption: Yes (n=214)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ASAT: >3 to 5 × ULN, Interruption: No (n=214)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ASAT: >5 × ULN, Adjustment: Yes (n=214)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ASAT: >5 × ULN, Interruption: Yes (n=214)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ASAT: >5 × ULN, Interruption: No (n=214)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=282)	1.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ALAT: >1 to 3 × ULN, Adjustment: No (n=282)	23.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ALAT: >1 to 3 × ULN, Interruption: Yes (n=282)	0.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ALAT: >1 to 3 × ULN, Interruption: No (n=282)	24.1 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ALAT: >5 × ULN, Interruption: Yes (n=282)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ALAT: >5 × ULN, Interruption: No (n=282)	0.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ANC: <0.5, Adjustment: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ANC: 0.5 to 1, Interruption: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 ANC: 0.5 to 1, Interruption: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 Platelets: <50, Interruption: Yes (n=378)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 Platelets: 50 to 100, Adjustment: No (n=378)	0.3 percentage of participants

PRIMARY outcome

Timeframe: Week 20

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 20.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=518 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 Platelets: <50, Adjustment: Yes (n=352)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 Platelets: <50, Adjustment: No (n=352)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 Platelets: <50, Interruption: Yes (n=352)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 Platelets: <50, Interruption: No (n=352)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 Platelets: 50 to 100, Adjustment: Yes (n=352)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 Platelets: 50 to 100, Adjustment: No (n=352)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 Platelets: 50 to 100, Interruption: Yes (n=352)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 Platelets: 50 to 100, Interruption: No (n=352)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ASAT: >1 to 3 × ULN, Adjustment: No (n=175)	18.9 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ASAT: >1 to 3 × ULN, Interruption: Yes (n=175)	1.1 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ASAT: >1 to 3 × ULN, Interruption: No (n=175)	18.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=175)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ASAT: >3 to 5 × ULN, Interruption: Yes (n=175)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ASAT: >3 to 5 × ULN, Interruption: No (n=175)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ASAT: >5 × ULN, Adjustment: Yes (n=175)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ASAT: >5 × ULN, Interruption: Yes (n=175)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ASAT: >5 × ULN, Interruption: No (n=175)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=253)	0.8 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ALAT: >1 to 3 × ULN, Adjustment: No (n=253)	23.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ALAT: >1 to 3 × ULN, Interruption: Yes (n=253)	0.8 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ALAT: >1 to 3 × ULN, Interruption: No (n=253)	23.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=253)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ALAT: >3 to 5 × ULN, Adjustment: No (n=253)	1.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ALAT: >5 × ULN, Interruption: No (n=253)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ANC: <0.5, Adjustment: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ANC: <0.5, Adjustment: No (n=31)	3.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ANC: 0.5 to 1, Adjustment: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ANC: 0.5 to 1, Interruption: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ANC: 0.5 to 1, Interruption: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=175)	0.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ASAT: >3 to 5 × ULN, Adjustment: No (n=175)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ASAT: >5 × ULN, Adjustment: No (n=175)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ALAT: >3 to 5 × ULN, Interruption: Yes (n=253)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ALAT: >3 to 5 × ULN, Interruption: No (n=253)	1.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ALAT: >5 × ULN, Adjustment: Yes (n=253)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ALAT: >5 × ULN, Adjustment: No (n=253)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ALAT: >5 × ULN, Interruption: Yes (n=253)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ANC: <0.5, Interruption: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ANC: <0.5, Interruption: No (n=31)	3.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 ANC: 0.5 to 1, Adjustment: Yes (n=31)	0.0 percentage of participants

PRIMARY outcome

Timeframe: Week 24

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 24.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=524 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=189)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ASAT: >1 to 3 × ULN, Adjustment: No (n=189)	15.9 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ASAT: >1 to 3 × ULN, Interruption: No (n=189)	16.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=189)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ASAT: >5 × ULN, Adjustment: Yes (n=189)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ASAT: >5 × ULN, Adjustment: No (n=189)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ASAT: >5 × ULN, Interruption: Yes (n=189)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ASAT: >5 × ULN, Interruption: No (n=189)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=255)	0.8 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ALAT: >1 to 3 × ULN, Adjustment: No (n=255)	26.7 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ALAT: >1 to 3 × ULN, Interruption: Yes (n=255)	1.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ALAT: >1 to 3 × ULN, Interruption: No (n=255)	25.9 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=255)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ALAT: >3 to 5 × ULN, Adjustment: No (n=255)	0.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ALAT: >3 to 5 × ULN, Interruption: Yes (n=255)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ALAT: >3 to 5 × ULN, Interruption: No (n=255)	0.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ALAT: >5 × ULN, Interruption: No (n=255)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ANC: <0.5, Adjustment: Yes (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ANC: <0.5, Adjustment: No (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ANC: <0.5, Interruption: Yes (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ANC: <0.5, Interruption: No (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ANC: 0.5 to 1, Interruption: No (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 Platelets: <50, Adjustment: Yes (n=350)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 Platelets: <50, Adjustment: No (n=350)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 Platelets: <50, Interruption: Yes (n=352)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 Platelets: <50, Interruption: No (n=352)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 Platelets: 50 to 100, Adjustment: Yes (n=350)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 Platelets: 50 to 100, Adjustment: No (n=350)	0.9 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 Platelets: 50 to 100, Interruption: Yes (n=352)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 Platelets: 50 to 100, Interruption: No (n=352)	0.9 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ASAT: >1 to 3 × ULN, Interruption: Yes (n=189)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ASAT: >3 to 5 × ULN, Adjustment: No (n=189)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ASAT: >3 to 5 × ULN, Interruption: Yes (n=189)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ASAT: >3 to 5 × ULN, Interruption: No (n=189)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ALAT: >5 × ULN, Adjustment: Yes (n=255)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ALAT: >5 × ULN, Adjustment: No (n=255)	0.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ALAT: >5 × ULN, Interruption: Yes (n=255)	0.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ANC: 0.5 to 1, Adjustment: Yes (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ANC: 0.5 to 1, Adjustment: No (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 ANC: 0.5 to 1, Interruption: Yes (n=25)	0.0 percentage of participants

PRIMARY outcome

Timeframe: Week 28

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 28.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=471 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ASAT: >1 to 3 × ULN, Adjustment: No (n=173)	15.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ASAT: >1 to 3 × ULN, Interruption: Yes (n=173)	0.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ASAT: >3 to 5 × ULN, Interruption: No (n=173)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ASAT: >5 × ULN, Adjustment: Yes (n=173)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ASAT: >5 × ULN, Adjustment: No (n=173)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ASAT: >5 × ULN, Interruption: Yes (n=173)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ASAT: >5 × ULN, Interruption: No (n=173)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ALAT: >1 to 3 × ULN, Interruption: Yes (n=233)	1.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ALAT: >1 to 3 × ULN, Interruption: No (n=233)	21.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=233)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ALAT: >3 to 5 × ULN, Adjustment: No (n=233)	1.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ALAT: >3 to 5 × ULN, Interruption: Yes (n=233)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ALAT: >3 to 5 × ULN, Interruption: No (n=233)	1.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ALAT: >5 × ULN, Adjustment: Yes (n=233)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ALAT: >5 × ULN, Adjustment: No (n=233)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ALAT: >5 × ULN, Interruption: Yes (n=233)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ALAT: >5 × ULN, Interruption: No (n=233)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ANC: <0.5, Adjustment: Yes (n=28)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ANC: <0.5, Adjustment: No (n=28)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ANC: <0.5, Interruption: Yes (n=28)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ANC: <0.5, Interruption: No (n=28)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ANC: 0.5 to 1, Adjustment: Yes (n=28)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ANC: 0.5 to 1, Adjustment: No (n=28)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ANC: 0.5 to 1, Interruption: Yes (n=28)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ANC: 0.5 to 1, Interruption: No (n=28)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 Platelets: <50, Adjustment: No (n=333)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 Platelets: <50, Interruption: Yes (n=333)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 Platelets: <50, Interruption: No (n=333)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 Platelets: 50 to 100, Adjustment: Yes (n=333)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 Platelets: 50 to 100, Adjustment: No (n=333)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 Platelets: 50 to 100, Interruption: No (n=333)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=173)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ASAT: >1 to 3 × ULN, Interruption: No (n=173)	15.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=173)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ASAT: >3 to 5 × ULN, Adjustment: No (n=173)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ASAT: >3 to 5 × ULN, Interruption: Yes (n=173)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=233)	0.9 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 ALAT: >1 to 3 × ULN, Adjustment: No (n=233)	21.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 Platelets: <50, Adjustment: Yes (n=333)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 Platelets: 50 to 100, Interruption: Yes (n=333)	0.0 percentage of participants

PRIMARY outcome

Timeframe: Week 32

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 32.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=473 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=163)	1.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ASAT: >1 to 3 × ULN, Adjustment: No (n=163)	12.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ASAT: >1 to 3 × ULN, Interruption: Yes (n=163)	0.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=163)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ASAT: >3 to 5 × ULN, Adjustment: No (n=163)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ASAT: >3 to 5 × ULN, Interruption: Yes (n=163)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ASAT: >3 to 5 × ULN, Interruption: No (n=163)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ASAT: >5 × ULN, Adjustment: Yes (n=163)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ASAT: >5 × ULN, Adjustment: No (n=163)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ASAT: >5 × ULN, Interruption: Yes (n=163)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ASAT: >5 × ULN, Interruption: No (n=163)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ALAT: >1 to 3 × ULN, Adjustment: No (n=225)	21.8 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ALAT: >1 to 3 × ULN, Interruption: Yes (n=225)	0.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=225)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ALAT: >3 to 5 × ULN, Adjustment: No (n=225)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ALAT: >3 to 5 × ULN, Interruption: Yes (n=225)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ALAT: >3 to 5 × ULN, Interruption: No (n=225)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ALAT: >5 × ULN, Adjustment: Yes (n=225)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ALAT: >5 × ULN, Adjustment: No (n=225)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ALAT: >5 × ULN, Interruption: Yes (n=225)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ALAT: >5 × ULN, Interruption: No (n=225)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ANC: <0.5, Adjustment: Yes (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ANC: <0.5, Adjustment: No (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ANC: <0.5, Interruption: Yes (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ANC: <0.5, Interruption: No (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ANC: 0.5 to 1, Adjustment: Yes (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ANC: 0.5 to 1, Adjustment: No (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ANC: 0.5 to 1, Interruption: Yes (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 Platelets: <50, Adjustment: Yes (n=309)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 Platelets: <50, Adjustment: No (n=309)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 Platelets: <50, Interruption: Yes (n=309)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 Platelets: <50, Interruption: No (n=309)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 Platelets: 50 to 100, Adjustment: Yes (n=309)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 Platelets: 50 to 100, Adjustment: No (n=309)	0.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 Platelets: 50 to 100, Interruption: Yes (n=309)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 Platelets: 50 to 100, Interruption: No (n=309)	0.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ASAT: >1 to 3 × ULN, Interruption: No (n=163)	12.9 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=225)	1.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ALAT: >1 to 3 × ULN, Interruption: No (n=225)	22.7 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 ANC: 0.5 to 1, Interruption: No (n=26)	0.0 percentage of participants

PRIMARY outcome

Timeframe: Week 36

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 36.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=421 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=143)	0.7 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ASAT: >1 to 3 × ULN, Adjustment: No (n=143)	19.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ASAT: >1 to 3 × ULN, Interruption: No (n=143)	20.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=143)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ASAT: >3 to 5 × ULN, Adjustment: No (n=143)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ASAT: >3 to 5 × ULN, Interruption: Yes (n=143)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ASAT: >3 to 5 × ULN, Interruption: No (n=143)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ASAT: >5 × ULN, Adjustment: Yes (n=143)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ASAT: >5 × ULN, Adjustment: No (n=143)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ASAT: >5 × ULN, Interruption: Yes (n=143)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ASAT: >5 × ULN, Interruption: No (n=143)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ALAT: >1 to 3 × ULN, Interruption: Yes (n=194)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=194)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ALAT: >3 to 5 × ULN, Adjustment: No (n=194)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ALAT: >3 to 5 × ULN, Interruption: Yes (n=194)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ALAT: >5 × ULN, Adjustment: Yes (n=194)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ALAT: >5 × ULN, Adjustment: No (n=194)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ALAT: >5 × ULN, Interruption: Yes (n=194)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ALAT: >5 × ULN, Interruption: No (n=194)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ANC: <0.5, Adjustment: Yes (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ANC: <0.5, Adjustment: No (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ANC: <0.5, Interruption: Yes (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ANC: <0.5, Interruption: No (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ANC: 0.5 to 1, Adjustment: Yes (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ASAT: >1 to 3 × ULN, Interruption: Yes (n=143)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=194)	1.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ALAT: >1 to 3 × ULN, Adjustment: No (n=194)	23.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ALAT: >1 to 3 × ULN, Interruption: No (n=194)	24.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ALAT: >3 to 5 × ULN, Interruption: No (n=194)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ANC: 0.5 to 1, Adjustment: No (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ANC: 0.5 to 1, Interruption: Yes (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 ANC: 0.5 to 1, Interruption: No (n=25)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 Platelets: <50, Adjustment: Yes (n=282)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 Platelets: <50, Adjustment: No (n=282)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 Platelets: <50, Interruption: Yes (n=282)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 Platelets: <50, Interruption: No (n=282)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 Platelets: 50 to 100, Adjustment: Yes (n=282)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 Platelets: 50 to 100, Adjustment: No (n=282)	1.1 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 Platelets: 50 to 100, Interruption: Yes (n=282)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 Platelets: 50 to 100, Interruption: No (n=282)	1.1 percentage of participants

PRIMARY outcome

Timeframe: Week 40

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 40.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=434 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 Platelets: 50 to 100, Adjustment: No (n=296)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 Platelets: 50 to 100, Interruption: No (n=296)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ANC: 0.5 to 1, Interruption: Yes (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ANC: 0.5 to 1, Interruption: No (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 Platelets: <50, Adjustment: Yes (n=296)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 Platelets: <50, Adjustment: No (n=296)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 Platelets: <50, Interruption: Yes (n=296)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 Platelets: <50, Interruption: No (n=296)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 Platelets: 50 to 100, Adjustment: Yes (n=296)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 Platelets: 50 to 100, Interruption: Yes (n=296)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=138)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ASAT: >1 to 3 × ULN, Adjustment: No (n=138)	20.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ASAT: >1 to 3 × ULN, Interruption: Yes (n=138)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ASAT: >1 to 3 × ULN, Interruption: No (n=138)	20.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=138)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ASAT: >3 to 5 × ULN, Adjustment: No (n=138)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ASAT: >3 to 5 × ULN, Interruption: Yes (n=138)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ASAT: >3 to 5 × ULN, Interruption: No (n=138)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ASAT: >5 × ULN, Adjustment: Yes (n=138)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ASAT: >5 × ULN, Adjustment: No (n=138)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ASAT: >5 × ULN, Interruption: Yes (n=138)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ASAT: >5 × ULN, Interruption: No (n=138)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=202)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ALAT: >1 to 3 × ULN, Adjustment: No (n=202)	21.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ALAT: >1 to 3 × ULN, Interruption: Yes (n=202)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ALAT: >1 to 3 × ULN, Interruption: No (n=202)	21.8 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=202)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ALAT: >3 to 5 × ULN, Adjustment: No (n=202)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ALAT: >3 to 5 × ULN, Interruption: Yes (n=202)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ALAT: >3 to 5 × ULN, Interruption: No (n=202)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ALAT: >5 × ULN, Adjustment: Yes (n=202)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ALAT: >5 × ULN, Adjustment: No (n=202)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ALAT: >5 × ULN, Interruption: Yes (n=202)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ALAT: >5 × ULN, Interruption: No (n=202)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ANC: <0.5, Adjustment: Yes (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ANC: <0.5, Adjustment: No (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ANC: <0.5, Interruption: Yes (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ANC: <0.5, Interruption: No (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ANC: 0.5 to 1, Adjustment: Yes (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 ANC: 0.5 to 1, Adjustment: No (n=22)	0.0 percentage of participants

PRIMARY outcome

Timeframe: Week 44

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 44.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=415 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=140)	0.7 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ASAT: >1 to 3 × ULN, Adjustment: No (n=140)	15.7 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ASAT: >1 to 3 × ULN, Interruption: Yes (n=140)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ASAT: >1 to 3 × ULN, Interruption: No (n=140)	16.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=140)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ASAT: >3 to 5 × ULN, Adjustment: No (n=140)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ASAT: >3 to 5 × ULN, Interruption: Yes (n=140)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ASAT: >3 to 5 × ULN, Interruption: No (n=140)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ASAT: >5 × ULN, Adjustment: Yes (n=140)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ASAT: >5 × ULN, Adjustment: No (n=140)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ASAT: >5 × ULN, Interruption: Yes (n=140)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ASAT: >5 × ULN, Interruption: No (n=140)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=197)	1.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ALAT: >1 to 3 × ULN, Adjustment: No (n=197)	24.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ALAT: >1 to 3 × ULN, Interruption: Yes (n=197)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ALAT: >1 to 3 × ULN, Interruption: No (n=197)	24.9 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=197)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ALAT: >3 to 5 × ULN, Adjustment: No (n=197)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ALAT: >3 to 5 × ULN, Interruption: Yes (n=197)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ALAT: >3 to 5 × ULN, Interruption: No (n=197)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ALAT: >5 × ULN, Adjustment: Yes (n=197)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ALAT: >5 × ULN, Adjustment: No (n=197)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ALAT: >5 × ULN, Interruption: Yes (n=197)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ALAT: >5 × ULN, Interruption: No (n=197)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ANC: <0.5, Adjustment: Yes (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ANC: <0.5, Adjustment: No (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ANC: <0.5, Interruption: Yes (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ANC: <0.5, Interruption: No (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ANC: 0.5 to 1, Adjustment: Yes (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ANC: 0.5 to 1, Adjustment: No (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ANC: 0.5 to 1, Interruption: Yes (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 ANC: 0.5 to 1, Interruption: No (n=26)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 Platelets: <50, Adjustment: Yes (n=279)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 Platelets: <50, Adjustment: No (n=279)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 Platelets: <50, Interruption: Yes (n=279)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 Platelets: <50, Interruption: No (n=279)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 Platelets: 50 to 100, Adjustment: Yes (n=279)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 Platelets: 50 to 100, Adjustment: No (n=279)	0.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 Platelets: 50 to 100, Interruption: Yes (n=279)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 Platelets: 50 to 100, Interruption: No (n=279)	0.4 percentage of participants

PRIMARY outcome

Timeframe: Week 48

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 48.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=414 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=130)	1.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 Platelets: 50 to 100, Interruption: Yes (n=287)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ASAT: >5 × ULN, Interruption: No (n=131)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ASAT: >1 to 3 × ULN, Adjustment: No (n=130)	16.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ASAT: >1 to 3 × ULN, Interruption: Yes (n=131)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ASAT: >1 to 3 × ULN, Interruption: No (n=131)	17.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=130)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ASAT: >3 to 5 × ULN, Adjustment: No (n=130)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ASAT: >3 to 5 × ULN, Interruption: Yes (n=131)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ASAT: >3 to 5 × ULN, Interruption: No (n=131)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ASAT: >5 × ULN, Adjustment: Yes (n=130)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ASAT: >5 × ULN, Adjustment: No (n=130)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ASAT: >5 × ULN, Interruption: Yes (n=131)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=190)	1.1 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ALAT: >1 to 3 × ULN, Adjustment: No (n=190)	21.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ALAT: >1 to 3 × ULN, Interruption: Yes (n=191)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ALAT: >1 to 3 × ULN, Interruption: No (n=191)	22.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=190)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ALAT: >3 to 5 × ULN, Adjustment: No (n=190)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ALAT: >3 to 5 × ULN, Interruption: Yes (n=191)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ALAT: >3 to 5 × ULN, Interruption: No (n=191)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ALAT: >5 × ULN, Adjustment: Yes (n=190)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ALAT: >5 × ULN, Adjustment: No (n=190)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ALAT: >5 × ULN, Interruption: Yes (n=191)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ALAT: >5 × ULN, Interruption: No (n=191)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ANC: <0.5, Adjustment: Yes (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ANC: <0.5, Adjustment: No (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ANC: <0.5, Interruption: Yes (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ANC: <0.5, Interruption: No (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ANC: 0.5 to 1, Adjustment: Yes (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ANC: 0.5 to 1, Adjustment: No (n=22)	4.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ANC: 0.5 to 1, Interruption: Yes (n=22)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 ANC: 0.5 to 1, Interruption: No (n=22)	4.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 Platelets: <50, Adjustment: Yes (n=286)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 Platelets: <50, Adjustment: No (n=286)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 Platelets: <50, Interruption: Yes (n=287)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 Platelets: <50, Interruption: No (n=287)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 Platelets: 50 to 100, Adjustment: Yes (n=286)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 Platelets: 50 to 100, Adjustment: No (n=286)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 Platelets: 50 to 100, Interruption: No (n=287)	0.3 percentage of participants

PRIMARY outcome

Timeframe: Week 52

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 52.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=476 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ANC: 0.5 to 1, Interruption: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ANC: <0.5, Interruption: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ANC: <0.5, Interruption: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ANC: 0.5 to 1, Adjustment: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ANC: 0.5 to 1, Adjustment: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ANC: 0.5 to 1, Interruption: No (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 Platelets: <50, Adjustment: Yes (n=331)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 Platelets: <50, Adjustment: No (n=331)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 Platelets: <50, Interruption: Yes (n=331)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 Platelets: <50, Interruption: No (n=331)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 Platelets: 50 to 100, Adjustment: Yes (n=331)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 Platelets: 50 to 100, Adjustment: No (n=331)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 Platelets: 50 to 100, Interruption: Yes (n=331)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 Platelets: 50 to 100, Interruption: No (n=331)	0.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ASAT: >1 to 3 × ULN, Adjustment: Yes (n=160)	1.9 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ASAT: >1 to 3 × ULN, Adjustment: No (n=160)	18.1 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ASAT: >1 to 3 × ULN, Interruption: Yes (n=160)	2.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ASAT: >1 to 3 × ULN, Interruption: No (n=160)	17.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ASAT: >3 to 5 × ULN, Adjustment: Yes (n=160)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ASAT: >3 to 5 × ULN, Adjustment: No (n=160)	0.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ASAT: >3 to 5 × ULN, Interruption: Yes (n=160)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ASAT: >3 to 5 × ULN, Interruption: No (n=160)	0.6 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ASAT: >5 × ULN, Adjustment: Yes (n=160)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ASAT: >5 × ULN, Adjustment: No (n=160)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ASAT: >5 × ULN, Interruption: Yes (n=160)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ASAT: >5 × ULN, Interruption: No (n=160)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ALAT: >1 to 3 × ULN, Adjustment: Yes (n=220)	3.2 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ALAT: >1 to 3 × ULN, Adjustment: No (n=220)	22.7 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ALAT: >1 to 3 × ULN, Interruption: Yes (n=220)	1.4 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ALAT: >1 to 3 × ULN, Interruption: No (n=220)	24.1 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ALAT: >3 to 5 × ULN, Adjustment: Yes (n=220)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ALAT: >3 to 5 × ULN, Adjustment: No (n=220)	2.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ALAT: >3 to 5 × ULN, Interruption: Yes (n=220)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ALAT: >3 to 5 × ULN, Interruption: No (n=220)	2.3 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ALAT: >5 × ULN, Adjustment: Yes (n=220)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ALAT: >5 × ULN, Adjustment: No (n=220)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ALAT: >5 × ULN, Interruption: Yes (n=220)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ALAT: >5 × ULN, Interruption: No (n=220)	0.5 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ANC: <0.5, Adjustment: Yes (n=31)	0.0 percentage of participants
Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 ANC: <0.5, Adjustment: No (n=31)	0.0 percentage of participants

PRIMARY outcome

Timeframe: Baseline to end of treatment (up to 12 months)

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the number of participants who had at least one tocilizumab dose adjustment during the study.

The percentage of participants with any tocilizumab dose adjustment during the study was reported among all reasons given for tocilizumab dose adjustments, as provided in the CRF. The sum of all reasons may add up to \>100 percent (%) because more than one reason could be given for each dose change. In the table presented, "Other Reasons" refers to any reason other than those specified in categories. Similarly, "Other Laboratory Change" refers to a change in any laboratory parameter other than those specified in categories.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=199 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With Tocilizumab Dose Adjustments by Reason Not Specified Laboratory Change	0.5 percentage of participants
Percentage of Participants With Tocilizumab Dose Adjustments by Reason Weight Change	54.3 percentage of participants
Percentage of Participants With Tocilizumab Dose Adjustments by Reason Adverse Event/Non-RA Medical Cause	11.1 percentage of participants
Percentage of Participants With Tocilizumab Dose Adjustments by Reason Remission/RA Improvement	10.6 percentage of participants
Percentage of Participants With Tocilizumab Dose Adjustments by Reason Maximum Dose per SmPC	9.0 percentage of participants
Percentage of Participants With Tocilizumab Dose Adjustments by Reason RA Activity	8.5 percentage of participants
Percentage of Participants With Tocilizumab Dose Adjustments by Reason Dose Titration	6.5 percentage of participants
Percentage of Participants With Tocilizumab Dose Adjustments by Reason Other Reasons	5.5 percentage of participants
Percentage of Participants With Tocilizumab Dose Adjustments by Reason Participant Request	4.5 percentage of participants
Percentage of Participants With Tocilizumab Dose Adjustments by Reason Liver Enzyme Laboratory Change	4.0 percentage of participants
Percentage of Participants With Tocilizumab Dose Adjustments by Reason Neutrophil Laboratory Change	1.5 percentage of participants
Percentage of Participants With Tocilizumab Dose Adjustments by Reason Platelet Laboratory Change	0.5 percentage of participants
Percentage of Participants With Tocilizumab Dose Adjustments by Reason Other Laboratory Change	4.5 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-millimeter (mm) Visual Analog Scale (VAS). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in millimeters per hour (mm/h). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The score at Baseline was reported.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=728 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
28-Joint Disease Activity Score (DAS28) at Baseline	5.5 units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: Baseline to Week 4

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 4 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=516 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 4	-1.8 units on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 8 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=453 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 8	-2.3 units on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=424 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 12	-2.4 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 16 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=392 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 16	-2.6 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Baseline to Week 20

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 20 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=389 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 20	-2.6 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=389 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 24	-2.7 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Baseline to Week 28

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 28 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=341 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 28	-2.7 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Baseline to Week 32

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 32 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=356 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 32	-2.8 units on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: Baseline to Week 36

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=312 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 36	-2.9 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline to Week 40

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 40 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=326 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 40	-2.8 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline to Week 44

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 44 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=305 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 44	-3.0 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Baseline to Week 48

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 48 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=316 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 48	-2.9 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline to Week 52

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=353 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in DAS28 From Baseline to Week 52	-2.9 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for tenderness. The number of tender joints at Baseline was reported and could range from 0 to 28, where higher values represented more tender joints.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=823 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
TJC at Baseline	9.5 tender joints Standard Deviation 6.7

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=593 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in TJC From Baseline to Week 12	-5.2 tender joints Standard Deviation 6.3

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=540 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in TJC From Baseline to Week 24	-6.2 tender joints Standard Deviation 7.0

PRIMARY outcome

Timeframe: Baseline to Week 36

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=446 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in TJC From Baseline to Week 36	-6.6 tender joints Standard Deviation 6.8

PRIMARY outcome

Timeframe: Baseline to Week 52

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=492 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in TJC From Baseline to Week 52	-6.7 tender joints Standard Deviation 6.9

PRIMARY outcome

Timeframe: Baseline

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for swollenness. The number of swollen joints at Baseline was reported and could range from 0 to 28, where higher values represented more swollen joints.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=829 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
SJC at Baseline	8.1 swollen joints Standard Deviation 6.0

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=600 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in SJC From Baseline to Week 12	-4.6 swollen joints Standard Deviation 5.7

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=545 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in SJC From Baseline to Week 24	-5.2 swollen joints Standard Deviation 5.9

PRIMARY outcome

Timeframe: Baseline to Week 36

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=446 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in SJC From Baseline to Week 36	-6.0 swollen joints Standard Deviation 6.1

PRIMARY outcome

Timeframe: Baseline to Week 52

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=496 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in SJC From Baseline to Week 52	-6.0 swollen joints Standard Deviation 6.0

PRIMARY outcome

Timeframe: Baseline

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=821 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
VAS Score of Participant-Assessed Disease Activity at Baseline	66.8 mm Standard Deviation 20.0

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=611 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 12	-28.0 mm Standard Deviation 25.0

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=558 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 24	-32.0 mm Standard Deviation 25.5

PRIMARY outcome

Timeframe: Baseline to Week 36

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=461 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 36	-36.0 mm Standard Deviation 27.2

PRIMARY outcome

Timeframe: Baseline to Week 52

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=515 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 52	-36.4 mm Standard Deviation 26.8

PRIMARY outcome

Timeframe: Baseline

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=819 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
VAS Score of Physician-Assessed Disease Activity at Baseline	62.7 mm Standard Deviation 18.6

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=605 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 12	-29.6 mm Standard Deviation 23.3

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=552 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 24	-34.5 mm Standard Deviation 23.7

PRIMARY outcome

Timeframe: Baseline to Week 36

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=455 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 36	-37.3 mm Standard Deviation 25.1

PRIMARY outcome

Timeframe: Baseline to Week 52

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=513 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 52	-38.5 mm Standard Deviation 25.3

PRIMARY outcome

Timeframe: Baseline to Week 4

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 4 visit and the DAS28 change from Baseline to Week 4. Participants with a score less than or equal to (≤) 3.2 and reduction of \>1.2 points were assessed as having a "Good" response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score ≤5.1 with reduction of \>0.6 to ≤1.2 points, were assessed as having a "Moderate" response. Participants with a score \>5.1 with reduction of \>0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as "No Improvement".

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=516 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 4 Good	31.8 percentage of participants
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 4 Moderate	44.2 percentage of participants
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 4 No Improvement	24.0 percentage of participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 12 visit and the DAS28 change from Baseline to Week 12. Participants with a score ≤3.2 and reduction of \>1.2 points were assessed as having a "Good" response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score ≤5.1 with reduction of \>0.6 to ≤1.2 points, were assessed as having a "Moderate" response. Participants with a score \>5.1 with reduction of \>0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as "No Improvement".

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=424 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With EULAR Response at Week 12 Good	50.0 percentage of participants
Percentage of Participants With EULAR Response at Week 12 Moderate	36.3 percentage of participants
Percentage of Participants With EULAR Response at Week 12 No Improvement	13.7 percentage of participants

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 24 visit and the DAS28 change from Baseline to Week 24. Participants with a score ≤3.2 and reduction of \>1.2 points were assessed as having a "Good" response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score ≤5.1 with reduction of \>0.6 to ≤1.2 points, were assessed as having a "Moderate" response. Participants with a score \>5.1 with reduction of \>0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as "No Improvement".

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=389 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With EULAR Response at Week 24 Good	54.8 percentage of participants
Percentage of Participants With EULAR Response at Week 24 Moderate	33.2 percentage of participants
Percentage of Participants With EULAR Response at Week 24 No Improvement	12.1 percentage of participants

PRIMARY outcome

Timeframe: Baseline to Week 36

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 36 visit and the DAS28 change from Baseline to Week 36. Participants with a score ≤3.2 and reduction of \>1.2 points were assessed as having a "Good" response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score ≤5.1 with reduction of \>0.6 to ≤1.2 points, were assessed as having a "Moderate" response. Participants with a score \>5.1 with reduction of \>0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as "No Improvement".

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=312 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With EULAR Response at Week 36 Good	60.3 percentage of participants
Percentage of Participants With EULAR Response at Week 36 Moderate	28.5 percentage of participants
Percentage of Participants With EULAR Response at Week 36 No Improvement	11.2 percentage of participants

PRIMARY outcome

Timeframe: Baseline to Week 52

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 52 visit and the DAS28 change from Baseline to Week 52. Participants with a score ≤3.2 and reduction of \>1.2 points were assessed as having a "Good" response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score ≤5.1 with reduction of \>0.6 to ≤1.2 points, were assessed as having a "Moderate" response. Participants with a score \>5.1 with reduction of \>0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as "No Improvement".

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=353 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With EULAR Response at Week 52 Moderate	26.6 percentage of participants
Percentage of Participants With EULAR Response at Week 52 Good	62.3 percentage of participants
Percentage of Participants With EULAR Response at Week 52 No Improvement	11.0 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Baseline.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=728 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With Low Disease Activity Score (LDAS) According to DAS28 at Baseline	5.1 percentage of participants

PRIMARY outcome

Timeframe: Week 12

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 12.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=459 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With LDAS According to DAS28 at Week 12	55.1 percentage of participants

PRIMARY outcome

Timeframe: Week 24

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 24.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=427 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With LDAS According to DAS28 at Week 24	59.3 percentage of participants

PRIMARY outcome

Timeframe: Week 36

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 36.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=349 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With LDAS According to DAS28 at Week 36	65.3 percentage of participants

PRIMARY outcome

Timeframe: Week 52

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 52.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=396 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With LDAS According to DAS28 at Week 52	66.4 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score \<2.6 at Baseline.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=728 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With Remission According to DAS28 at Baseline	2.5 percentage of participants

PRIMARY outcome

Timeframe: Week 12

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score \<2.6 at Week 12.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=459 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With Remission According to DAS28 at Week 12	41.8 percentage of participants

PRIMARY outcome

Timeframe: Week 24

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score \<2.6 at Week 24.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=427 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With Remission According to DAS28 at Week 24	45.7 percentage of participants

PRIMARY outcome

Timeframe: Week 36

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score \<2.6 at Week 36.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=349 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With Remission According to DAS28 at Week 36	52.4 percentage of participants

PRIMARY outcome

Timeframe: Week 52

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score \<2.6 at Week 52.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=396 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With Remission According to DAS28 at Week 52	55.1 percentage of participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 12.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=424 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With Minimum Clinically Important Improvement (MCII) According to DAS28 at Week 12	76.7 percentage of participants

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 24.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=389 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With MCII According to DAS28 at Week 24	82.0 percentage of participants

PRIMARY outcome

Timeframe: Baseline to Week 36

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 36.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=312 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With MCII According to DAS28 at Week 36	84.0 percentage of participants

PRIMARY outcome

Timeframe: Baseline to Week 52

Population: All Enrolled Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 52.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=353 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With MCII According to DAS28 at Week 52	84.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline to end of treatment (up to 12 months)

Population: All Enrolled Population

An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of tocilizumab. Worsened pre-existing conditions and laboratory or clinical tests that resulted in change or discontinuation of treatment were reported as AEs. The percentage of participants with treatment-related AEs (also known as adverse drug reactions) was reported as a separate endpoint and included both serious and non-serious AEs. Those AEs with a causal relationship reported as "definite", "probably", "possible", or "unlikely" were considered to be related to tocilizumab. If the causal relationship was reported as "unrelated", the AE was considered not related to tocilizumab treatment. Terms were reported verbatim as coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 12.0. The most common treatment-related AEs were reported, using those from the 10 highest incidence rate levels.

Outcome measures

Outcome measures
Measure	Tocilizumab for RA in Routine Practice n=850 Participants Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Bronchitis	3.4 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Rash	1.2 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Alopecia	1.2 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Gamma-glutamyltransferase increased	1.2 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Herpes zoster	1.2 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Dizziness	1.1 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Cystitis	0.9 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Liver function test abnormal	0.9 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Oral herpes	0.9 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Upper respiratory tract infection	0.9 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Urinary tract infection	0.9 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Any Treatment-Related AE	39.4 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Nasopharyngitis	2.9 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Pruritus	2.4 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Headache	2.1 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Hypercholesterolaemia	1.9 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Diarrhoea	1.4 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Hypertension	1.4 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Respiratory tract infection	1.4 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Sinusitis	1.4 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Leukopenia	1.3 percentage of participants
Percentage of Participants With AEs Considered Causally Related to Tocilizumab Nausea	1.3 percentage of participants

Adverse Events

Tocilizumab for RA in Routine Practice

Serious events: 104 serious events

Other events: 320 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tocilizumab for RA in Routine Practice n=850 participants at risk Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Blood and lymphatic system disorders Anaemia	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Blood and lymphatic system disorders Bone marrow toxicity	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Blood and lymphatic system disorders Hypochromic anaemia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Blood and lymphatic system disorders Thrombocytopenia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Acute myocardial infarction	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Angina unstable	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Arrhythmia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Atrial fibrillation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Cardiomyopathy	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Coronary artery disease	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Left ventricular failure	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Myocardial infarction	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Tachyarrhythmia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Diplopia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Retinal vein occlusion	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Visual impairment	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Abdominal hernia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Abdominal pain	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Anal haemorrhage	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Anorectal varices haemorrhage	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Colitis ulcerative	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Diarrhoea	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Gastritis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Ileus	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Large intestine perforation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Nausea	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Peritonitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Reflux oesophagitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Varices oesophageal	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Chest pain	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Chills	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Drug withdrawal syndrome	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Foreign body reaction	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders General physical health deterioration	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Impaired healing	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Influenza like illness	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Oedema	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Oedema peripheral	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Pain	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Pyrexia	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Ulcer	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Hepatobiliary disorders Cholecystitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Hepatobiliary disorders Cholelithiasis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Hepatobiliary disorders Cholestasis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Hepatobiliary disorders Gallbladder perforation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Hepatobiliary disorders Hepatic cirrhosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Hepatobiliary disorders Hepatitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Hepatobiliary disorders Hepatitis acute	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Hepatobiliary disorders Portal hypertension	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Immune system disorders Anaphylactic reaction	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Immune system disorders Hypersensitivity	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Abscess	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Arthritis bacterial	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Bronchitis	0.82% 7/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Bronchopneumonia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Bursitis infective	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Cellulitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Cystitis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Device related infection	0.47% 4/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Diverticulitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Ear infection	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Erysipelas	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Gangrene	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Gastroenteritis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Haematoma infection	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Herpes virus infection	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Herpes zoster	0.47% 4/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Infection	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Klebsiella infection	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Klebsiella sepsis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Nasopharyngitis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Oral herpes	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Pneumonia	0.47% 4/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Post procedural infection	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Pulmonary tuberculosis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Rash pustular	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Respiratory tract infection	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Salmonellosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Septic shock	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Sinusitis	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Skin infection	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Soft tissue infection	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Tracheobronchitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Urinary tract infection	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Wound infection	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Ankle fracture	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Fall	0.71% 6/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Femoral neck fracture	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Fibula fracture	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Fracture displacement	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Fractured coccyx	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Patella fracture	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Pelvic fracture	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Procedural site reaction	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Radius fracture	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Rib fracture	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Tibia fracture	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Alanine aminotransferase increased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Gamma-glutamyltransferase increased	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Haemoglobin decreased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Hepatic enzyme increased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Arthralgia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Arthritis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Arthropathy	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Back pain	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Bone fistula	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Bone pain	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Bursitis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Fistula	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Myalgia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Rheumatoid nodule	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Cerebrovascular accident	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Headache	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Presyncope	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Speech disorder	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Psychiatric disorders Acute psychosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Psychiatric disorders Panic attack	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Renal and urinary disorders Nephrolithiasis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Renal and urinary disorders Renal failure	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Rheumatoid lung	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Alopecia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Erythema	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Pain of skin	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Pruritus	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Psoriasis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Rash	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Skin disorder	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Skin necrosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Skin ulcer	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Urticaria	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Surgical and medical procedures Breast cyst excision	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Surgical and medical procedures Cardiac pacemaker insertion	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Surgical and medical procedures Knee arthroplasty	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Surgical and medical procedures Surgery	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Aortic thrombosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Deep vein thrombosis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Hypertension	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Iliac artery stenosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Peripheral arterial occlusive disease	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Thrombosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.

Other adverse events

Other adverse events
Measure	Tocilizumab for RA in Routine Practice n=850 participants at risk Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
Blood and lymphatic system disorders Anaemia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Blood and lymphatic system disorders Iron deficiency anaemia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Blood and lymphatic system disorders Leukopenia	1.4% 12/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Blood and lymphatic system disorders Lymphadenopathy	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Blood and lymphatic system disorders Neutropenia	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Blood and lymphatic system disorders Thrombocytopenia	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Angina pectoris	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Cardiovascular disorder	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Coronary artery disease	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Sinus bradycardia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Tachycardia	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Cardiac disorders Tachycardia paroxysmal	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Ear and labyrinth disorders Ear pain	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Ear and labyrinth disorders Eustachian tube disorder	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Ear and labyrinth disorders Tinnitus	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Ear and labyrinth disorders Vertigo	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Conjunctival cyst	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Conjunctival haemorrhage	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Conjunctivitis	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Diplopia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Dry eye	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Eczema eyelids	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Eye irritation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Eye pruritus	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Eyelid oedema	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Keratitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Macular degeneration	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Ocular hyperaemia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Photophobia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Retinal vein occlusion	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Sicca syndrome	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Vision blurred	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Eye disorders Visual impairment	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Abdominal discomfort	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Abdominal distension	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Abdominal pain	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Aphthous stomatitis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Colonic polyp	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Constipation	0.47% 4/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Diarrhoea	1.6% 14/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Diverticulum	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Dry mouth	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Enteritis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Gastric ulcer	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Gastritis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Gastrointestinal disorder	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Gingival bleeding	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Glossodynia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Haematochezia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Inguinal hernia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Lip ulceration	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Mouth ulceration	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Nausea	1.6% 14/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Oesophageal discomfort	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Oral discomfort	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Paraesthesia oral	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Periodontitis	0.59% 5/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Retching	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Stomatitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Tongue disorder	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Gastrointestinal disorders Vomiting	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Chest discomfort	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Chills	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Condition aggravated	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Drug ineffective	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Drug intolerance	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Fatigue	0.82% 7/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Impaired healing	0.47% 4/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Inflammation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Infusion site erythema	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Infusion site pruritus	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Malaise	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Mucosa vesicle	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Mucosal inflammation	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Oedema peripheral	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Pain	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
General disorders Pyrexia	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Hepatobiliary disorders Hepatitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Hepatobiliary disorders Liver disorder	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Immune system disorders Drug hypersensitivity	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Immune system disorders Hypersensitivity	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Abscess	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Abscess limb	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Acute tonsillitis	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Borrelia infection	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Bronchitis	3.2% 27/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Bronchitis bacterial	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Bronchitis viral	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Bronchopneumonia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Cellulitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Conjunctivitis bacterial	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Cystitis	0.82% 7/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Erysipelas	0.59% 5/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Erysipeloid	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Erythema migrans	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Folliculitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Fungal infection	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Fungal skin infection	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Gastroenteritis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Gastroenteritis norovirus	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Gastroenteritis viral	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Gastrointestinal infection	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Herpes simplex	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Herpes virus infection	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Herpes zoster	0.82% 7/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Hordeolum	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Infected skin ulcer	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Infection	0.47% 4/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Influenza	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Laryngitis	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Lobar pneumonia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Localised infection	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Measles	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Nasopharyngitis	3.3% 28/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Onychomycosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Oral candidiasis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Oral herpes	0.82% 7/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Otitis externa	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Otitis media	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Paronychia	0.47% 4/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Pharyngitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Pharyngotonsillitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Pneumonia	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Pyelonephritis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Rash pustular	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Respiratory tract infection	1.6% 14/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Respiratory tract infection viral	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Rhinitis	0.82% 7/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Salmonellosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Sinobronchitis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Sinusitis	1.1% 9/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Skin infection	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Soft tissue infection	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Tonsillitis	0.59% 5/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Tooth abscess	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Tracheobronchitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Upper respiratory tract infection	1.3% 11/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Urinary tract infection	0.82% 7/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Viral infection	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Viral upper respiratory tract infection	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Infections and infestations Wound infection	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Arthropod bite	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Excoriation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Fall	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Foot fracture	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Joint sprain	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Lower limb fracture	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Post procedural complication	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Procedural pain	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Skin laceration	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Injury, poisoning and procedural complications Tendon rupture	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Alanine aminotransferase increased	0.82% 7/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Aspartate aminotransferase increased	0.47% 4/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Blood bilirubin increased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Blood cholesterol increased	0.47% 4/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Blood creatinine increased	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Blood pressure increased	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Blood triglycerides increased	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations C-reactive protein abnormal	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Gamma-glutamyltransferase increased	1.1% 9/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Haemoglobin abnormal	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Haemoglobin decreased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Hepatic enzyme increased	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Intraocular pressure increased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Laboratory test abnormal	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Liver function test abnormal	0.94% 8/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Low density lipoprotein increased	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Lymphocyte percentage increased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Neutrophil count decreased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Rheumatoid factor increased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Serum ferritin decreased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Transaminases increased	0.82% 7/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Weight decreased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations Weight increased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations White blood cell count decreased	0.71% 6/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Investigations White blood cell count increased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Metabolism and nutrition disorders Dyslipidaemia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Metabolism and nutrition disorders Hypercholesterolaemia	1.9% 16/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Metabolism and nutrition disorders Hyperlipidaemia	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Arthralgia	0.59% 5/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Back pain	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Bone cyst	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Joint swelling	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Mobility decreased	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Muscle tightness	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Myalgia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Neck pain	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Pain in extremity	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.94% 8/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Rheumatoid nodule	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Synovial cyst	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Dizziness	1.1% 9/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Dysaesthesia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Headache	2.0% 17/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Migraine	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Paraesthesia	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Polyneuropathy	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Post herpetic neuralgia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Sciatica	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Nervous system disorders Sensory disturbance	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Psychiatric disorders Aggression	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Psychiatric disorders Agitation	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Psychiatric disorders Depression	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Psychiatric disorders Restlessness	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Psychiatric disorders Sleep disorder	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Renal and urinary disorders Bladder irritation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Renal and urinary disorders Leukocyturia	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Renal and urinary disorders Urge incontinence	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Reproductive system and breast disorders Amenorrhoea	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Reproductive system and breast disorders Prostatitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Cough	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Oropharyngeal blistering	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Respiratory, thoracic and mediastinal disorders Tonsillar disorder	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Acne	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Alopecia	1.2% 10/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Blood blister	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Dermatitis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Dermatosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Dry skin	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Dyshidrosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Eczema	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Erythema	0.71% 6/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Hypertrichosis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Ingrowing nail	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Neuropathic ulcer	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Night sweats	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Pruritus	2.0% 17/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Psoriasis	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Purpura	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Rash	1.1% 9/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Rash papular	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Rash pruritic	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Rosacea	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Skin induration	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Skin reaction	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Skin ulcer	0.47% 4/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Skin warm	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Skin and subcutaneous tissue disorders Urticaria	0.35% 3/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Social circumstances Menopause	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Surgical and medical procedures Arthrodesis	0.24% 2/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Surgical and medical procedures Cataract operation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Surgical and medical procedures Foot operation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Surgical and medical procedures Haemorrhoid operation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Surgical and medical procedures Hip arthroplasty	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Surgical and medical procedures Shoulder arthroplasty	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Surgical and medical procedures Toe amputation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Blood pressure fluctuation	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Haematoma	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Hot flush	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Hypertension	1.5% 13/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Hypertensive crisis	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Lymphoedema	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Peripheral arterial occlusive disease	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.
Vascular disorders Venous thrombosis limb	0.12% 1/850 • Baseline to end of treatment (up to 12 months); assessed at Baseline and Weeks 4-8, 12-16, 20-24, 36, 52; assessments were also possible/optional at 4-week intervals between Baseline and Week 52 Analysis Population Description: All Enrolled Population. Participants were asked about AEs at each study visit.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER