Trial Outcomes & Findings for A Non-Interventional Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis (NCT NCT01672970)

NCT ID: NCT01672970

Last Updated: 2016-03-28

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 291 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-03-28

Participant Flow

Participant milestones

Measure	Rheumatoid Arthritis Participants Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria, in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Overall Study STARTED	291
Overall Study Treated	290
Overall Study COMPLETED	244
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Measure	Rheumatoid Arthritis Participants Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria, in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Overall Study Lack of Efficacy	12
Overall Study Adverse Event	18
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	5
Overall Study Other	9
Overall Study Enrolled but not treated	1

Baseline Characteristics

A Non-Interventional Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Rheumatoid Arthritis Participants n=290 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Age, Continuous	56.14 years STANDARD_DEVIATION 12.26 • n=5 Participants
Sex/Gender, Customized Female	261 participants n=5 Participants
Sex/Gender, Customized Male	28 participants n=5 Participants
Sex/Gender, Customized Missing	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: FAS population

Outcome measures

Measure	RA Participants n=290 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation	81 percentage of participants Interval 76.8 to 86.0

SECONDARY outcome

Timeframe: Baseline

Population: FAS population

Systemic manifestations of RA at baseline included anemia, fatigue, conventional risk factor(s) for cardiovascular disease, C-reactive protein (CRP) above upper limit of normal rheumatoid nodules, rheumatoid vasculitis, and interstitial lung disease.

Outcome measures

Measure	RA Participants n=290 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants With Systemic Manifestations of RA at Baseline	13.8 percentage of participants Interval 10.0 to 18.3

SECONDARY outcome

Timeframe: Prior to study (8 weeks) to Baseline

Population: FAS population

DMARDs exposure was evaluated for all participants. "Prior DMARDs treatment" included participants, who were treated with DMARDs 8 weeks according to physician's discretion before being included in the study. "DMARDs treatment at baseline" included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ.

Outcome measures

Measure	RA Participants n=290 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants Who Stopped DMARDs Prior to Start of Study and at Baseline	60.70 percentage of participants Interval 54.8 to 66.3

SECONDARY outcome

Timeframe: Baseline

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.

DMARDs exposure was evaluated for all participants. DMARDs treatment at baseline included participants, who were receiving DMARDs when they were included in the study and discontinued at baseline and not used as concomitant medication to TCZ.

Outcome measures

Measure	RA Participants n=176 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants With Reason for DMARDs Withdrawal at Baseline Lack of efficacy	12.1 percentage of participants
Percentage of Participants With Reason for DMARDs Withdrawal at Baseline Intolerance	22.1 percentage of participants
Percentage of Participants With Reason for DMARDs Withdrawal at Baseline Unspecified	7.2 percentage of participants
Percentage of Participants With Reason for DMARDs Withdrawal at Baseline Unknown	19.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS population

Outcome measures

Measure	RA Participants n=290 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Number of Previous Biologic RA Treatments Received by Participants Abatacept	4 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Aceclofenac/Indometacin	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Aceclofenac	26 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Adalimumab	83 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Aspirin	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Azathiopirin	16 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Betamethasone	7 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Betamethasone/dipropionate/betamethasone sodium ph	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Celecoxib	6 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Certolizumab pegol	63 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Chloropyramine	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Chloroquine	7 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Ciclosporin	9 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Dexibuprofen	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Diclofenac	27 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Diclofenac/orphenadrine	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Dipyrone	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Etanercept	77 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Etoricoxib	28 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Flurbiprofen	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Gold	30 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Golimumab	35 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Hydroxychloroquine	95 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Ibuprofen	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Indometacin	2 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Infliximab	66 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Ketoprofen	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Leflunomide	174 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Meloxicam	29 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Methotrexate	294 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Methylprednisolone	277 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Nabumetone	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Naproxen	13 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Naproxen sodium	3 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Niflumic acid	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Nimesulide	13 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Paracetamol	6 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Paracetamol/Tramadol	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Penicillamine	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Penicillin G sodium	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Phenylbutazone	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Piroxicam	3 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Prednisolone	10 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Rituximab	17 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Sulfasalazine	171 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Tocilizumab	2 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Tramadol	30 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Triamcinolone	2 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Triamcinolone acetonide	3 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Triamcinolone hexacetonide	1 biologic treatments
Number of Previous Biologic RA Treatments Received by Participants Valdecoxib	1 biologic treatments

SECONDARY outcome

Timeframe: Baseline

Population: Per protocol population included all participants who had a valid tocilizumab administration assessment at 6-month time window and without any protocol violations.

The duration of previous biologic RA treatments was classified in to two categories: less than (<) 6 months and greater than (>) 6 months.

Outcome measures

Measure	RA Participants n=232 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants With Duration of Previous Biologic RA Treatments <6 months	0.0 percentage of participants
Percentage of Participants With Duration of Previous Biologic RA Treatments >6 months	100.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.

Lack of efficacy was determined as per physicians' discretion. Intolerance was defined as the participant could not be treated due to safety reason (adverse events).

Outcome measures

Measure	RA Participants n=170 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments Lack of efficacy	42.1 percentage of participants
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments Intolerance	11.7 percentage of participants
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments Unspecified	4.5 percentage of participants
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments Unknown	0.3 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: FAS population

Only those participants that had dose modifications were reported.

Outcome measures

Measure	RA Participants n=290 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Number of Participants With Reasons for Dose Modification for TCZ Adverse event	17 participants
Number of Participants With Reasons for Dose Modification for TCZ Normalization of absolute neutrophil count	3 participants
Number of Participants With Reasons for Dose Modification for TCZ Unspecified	6 participants

SECONDARY outcome

Timeframe: 6 months

Population: FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.

TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.

Outcome measures

Measure	RA Participants n=237 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Mean Dose of TCZ at 6 Months	7.8926 milligrams per kilogram {mg/kg) Standard Deviation 0.57949

SECONDARY outcome

Timeframe: 6 months

Population: FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.

TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.

Outcome measures

Measure	RA Participants n=284 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Mean Dosing Interval of Treatment at 6 Months	31.79 days Standard Deviation 5.81

SECONDARY outcome

Timeframe: 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.

The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.

Outcome measures

Measure	RA Participants n=46 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons Intolerable adverse events	6.2 percentage of participants
Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons Lack of efficacy	4.1 percentage of participants
Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons Other Unspecified reason	5.5 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: Per protocol population

The number of participants who reported restoration of initial dosing regimen of TCZ for 84.00, 133.00, 158.00, 2.3.00 and 206.00 days, were reported.

Outcome measures

Measure	RA Participants n=232 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Number of Participants With Restoration of Initial Dosing Regimen of TCZ 84.00 days	1 participants
Number of Participants With Restoration of Initial Dosing Regimen of TCZ 133.00 days	1 participants
Number of Participants With Restoration of Initial Dosing Regimen of TCZ 158.00 days	2 participants
Number of Participants With Restoration of Initial Dosing Regimen of TCZ 203.00 days	1 participants
Number of Participants With Restoration of Initial Dosing Regimen of TCZ 206.00 days	1 participants

SECONDARY outcome

Timeframe: 6 months

Population: FAS population

A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.

Outcome measures

Measure	RA Participants n=290 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants Adhered to the Dosing Regimen Recommended by Physician for TCZ Adverse events	1.38 percentage of participants
Percentage of Participants Adhered to the Dosing Regimen Recommended by Physician for TCZ Other reasons	1.38 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: FAS population

TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.

Outcome measures

Measure	RA Participants n=290 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants on Tocilizumab Monotherapy	40.0 percentage of participants Interval 34.3 to 45.9

SECONDARY outcome

Timeframe: 6 months

Population: FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.

Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.

Outcome measures

Measure	RA Participants n=73 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants With Reason for DMARD Withdrawal Lack of efficacy	12.3 percentage of participants
Percentage of Participants With Reason for DMARD Withdrawal Intolerance	67.1 percentage of participants
Percentage of Participants With Reason for DMARD Withdrawal Oher unspecified reason	20.5 percentage of participants
Percentage of Participants With Reason for DMARD Withdrawal Withdrew informed consent	0.7 percentage of participants
Percentage of Participants With Reason for DMARD Withdrawal Other	3.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28.

Outcome measures

Measure	RA Participants n=259 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Tender Joint Count (28 Joints) at Months 3 and 6 Month 3 (n=259)	-10.2703 joint count Standard Deviation 7.41544
Change From Baseline in Tender Joint Count (28 Joints) at Months 3 and 6 Month 6 (n=215)	-10.6744 joint count Standard Deviation 7.64432

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.

Outcome measures

Measure	RA Participants n=23 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Tender Joint Count (68 Joints) at Months 3 and 6 Month 6 (n=21)	-60.0820 joint count Standard Deviation 51.74519
Change From Baseline in Tender Joint Count (68 Joints) at Months 3 and 6 Month 3 (n=23)	-48.2904 joint count Standard Deviation 49.94400

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28.

Outcome measures

Measure	RA Participants n=259 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Swollen Joint Count (28 Joints) at Months 3 and 6 Month 3 (n=259)	-6.6641 joint count Standard Deviation 6.22130
Change From Baseline in Swollen Joint Count (28 Joints) at Months 3 and 6 Month 6 (n=215)	-7.0651 joint count Standard Deviation 6.28047

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 66 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.

Outcome measures

Measure	RA Participants n=20 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Swollen Joint Count (66 Joints) at Months 3 and 6 Month 3 (n=20)	-70.6711 joint count Standard Deviation 35.24487
Change From Baseline in Swollen Joint Count (66 Joints) at Months 3 and 6 Month 6 (n=17)	-80.9244 joint count Standard Deviation 27.34339

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and Participant's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, higher score=more disease activity. DAS28 <3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.

Outcome measures

Measure	RA Participants n=250 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Months 3 and 6 Month 3 (n=250)	2.6156 units on a scale Standard Deviation 1.23416
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Months 3 and 6 Month 6 (n=209)	2.2703 units on a scale Standard Deviation 1.09059

SECONDARY outcome

Timeframe: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Months 6) and Visit 8 (Final Visit; within 2 weeks after 6months observation period)

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.

Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB >=-0.6 and DAS28 >5.1 or CFB >=-0.6.

Outcome measures

Measure	RA Participants n=252 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants With European League Against Rheumatism (EULAR) Response Visit 2 (Month 1)	75.2 percentage of participants Interval 69.8 to 80.0
Percentage of Participants With European League Against Rheumatism (EULAR) Response Visit 3 (Month 2)	7.2 percentage of participants Interval 4.5 to 10.9
Percentage of Participants With European League Against Rheumatism (EULAR) Response Visit 4 (Month 3)	3.1 percentage of participants Interval 1.4 to 5.8
Percentage of Participants With European League Against Rheumatism (EULAR) Response Visit 5 (Month 4)	0.7 percentage of participants Interval 0.1 to 2.5
Percentage of Participants With European League Against Rheumatism (EULAR) Response Visit 6 (Month 5)	0.3 percentage of participants Interval 0.0 to 1.9
Percentage of Participants With European League Against Rheumatism (EULAR) Response Visit 7 (Month 6)	0.3 percentage of participants Interval 0.0 to 1.9
Percentage of Participants With European League Against Rheumatism (EULAR) Response Visit 8 (Final Visit)	0 percentage of participants Interval 0.0 to 1.3

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of <=3.3 represented clinical remission, a score of >3.4 to <=11.0 represented low disease activity, a score of >11 to <=26.0 represented moderate disease activity and a score of >26.0 represented high (or severe) disease.

Outcome measures

Measure	RA Participants n=185 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Months 3 and 6 Month 3 (n=185)	-45.4383 units on a scale Standard Deviation 38.24144
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Months 3 and 6 Month 6 (n=148)	-47.5846 units on a scale Standard Deviation 33.88556

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm VAS); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of <=2.8 represented clinical remission, a score of >2.8 to <=10.0 represented low disease activity, a score of >10.0 to <=22.0 represented moderate disease activity and a score of >22.0 represented high (or severe) disease.

Outcome measures

Measure	RA Participants n=206 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Months 3 and 6 Month 3 (n=206)	-24.6068 units on a scale Standard Deviation 14.41937
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Months 3 and 6 Month 6 (n=173)	-26.0046 units on a scale Standard Deviation 14.58529

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population

ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.

Outcome measures

Measure	RA Participants n=290 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants Who Achieved 20 Percent (%) Improvement in ACR (ACR20) Response Month 3	3.80 percentage of participants Interval 1.9 to 6.7
Percentage of Participants Who Achieved 20 Percent (%) Improvement in ACR (ACR20) Response Month 6	4.5 percentage of participants Interval 2.4 to 7.5

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population

ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.

Outcome measures

Measure	RA Participants n=290 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response Month 3	3.10 percentage of participants Interval 1.4 to 5.8
Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response Month 6	1.70 percentage of participants Interval 0.6 to 4.0

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population

ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.

Outcome measures

Measure	RA Participants n=290 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response Month 3	1.40 percentage of participants Interval 0.4 to 3.5
Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response Month 6	1.40 percentage of participants Interval 0.4 to 3.5

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population

ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR90 response required at least a 90% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.

Outcome measures

Measure	RA Participants n=290 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Percentage of Participants Who Achieved 90% Improvement in ACR (ACR90) Response Month 3	0.70 percentage of participants Interval 0.1 to 2.5
Percentage of Participants Who Achieved 90% Improvement in ACR (ACR90) Response Month 6	0.70 percentage of participants Interval 0.1 to 2.5

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.

Outcome measures

Measure	RA Participants n=214 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 Month 3 (n=214)	-37.3832 units on a scale Standard Deviation 21.41701
Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 Month 6 (n=177)	-43.9096 units on a scale Standard Deviation 20.78387

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

The Participant's Global Assessment of Disease Activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.

Outcome measures

Measure	RA Participants n=238 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Participant Global Assessment of Disease Activity at Months 3 and 6 Month 3 (n=238)	-33.2437 units on a scale Standard Deviation 24.64703
Change From Baseline in Participant Global Assessment of Disease Activity at Months 3 and 6 Month 6 (n=201)	-39.3930 units on a scale Standard Deviation 25.06551

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.

Outcome measures

Measure	RA Participants n=205 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Months 3 and 6 Month 3 (n=205)	0.4766 units on a scale Standard Deviation 0.62768
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Months 3 and 6 Month 6 (n=173)	0.5497 units on a scale Standard Deviation 0.63257

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).

Outcome measures

Measure	RA Participants n=198 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Participant's Assessment of Fatigue Using VAS at Months 3 and 6 Month 3 (n=198)	-26.4192 units on a scale Standard Deviation 26.05482
Change From Baseline in Participant's Assessment of Fatigue Using VAS at Months 3 and 6 Month 6 (n=162)	-32.5000 units on a scale Standard Deviation 25.94984

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain).

Outcome measures

Measure	RA Participants n=239 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Participant's Assessment of RA-Related Pain Using VAS at Months 3 and 6 Month 3 (n=239)	-31.0586 units on a scale Standard Deviation 23.45828
Change From Baseline in Participant's Assessment of RA-Related Pain Using VAS at Months 3 and 6 Month 6 (n=194)	-36.9948 units on a scale Standard Deviation 25.95782

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category.

Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.

Outcome measures

Measure	RA Participants n=151 Participants Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Change From Baseline in Particpant's Assessment of RA Morning Stiffness Assessed Using VAS at Months 3 and 6 Month 3 (n=151)	-25.7285 units on a scale Standard Deviation 26.61877
Change From Baseline in Particpant's Assessment of RA Morning Stiffness Assessed Using VAS at Months 3 and 6 Month 6 (n=117)	-32.5043 units on a scale Standard Deviation 26.08792

Adverse Events

Rheumatoid Arthritis Participants

Serious events: 17 serious events

Other events: 108 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rheumatoid Arthritis Participants n=290 participants at risk Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Blood and lymphatic system disorders Leucocytosis	0.34% 1/290 • Up to 6 months FAS population
Blood and lymphatic system disorders Neutropenia	0.34% 1/290 • Up to 6 months FAS population
Blood and lymphatic system disorders Pancytopenia	0.69% 2/290 • Up to 6 months FAS population
Ear and labyrinth disorders Vertigo	0.34% 1/290 • Up to 6 months FAS population
Eye disorders Keratitis	0.34% 1/290 • Up to 6 months FAS population
Eye disorders Diplopia	0.34% 1/290 • Up to 6 months FAS population
Eye disorders Ulcerative keratitis	0.34% 1/290 • Up to 6 months FAS population
Eye disorders Corneal disorders	0.34% 1/290 • Up to 6 months FAS population
Immune system disorders Anaphylactic reaction	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Sepsis	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Skin infection	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Erysipelas	0.69% 2/290 • Up to 6 months FAS population
Investigations Glomerular filtration rate increased	0.34% 1/290 • Up to 6 months FAS population
Investigations Hepatic enzyme increased	0.69% 2/290 • Up to 6 months FAS population
Investigations Neutrophil count increase	0.34% 1/290 • Up to 6 months FAS population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.34% 1/290 • Up to 6 months FAS population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.34% 1/290 • Up to 6 months FAS population
Nervous system disorders Hypotonia	0.34% 1/290 • Up to 6 months FAS population
Skin and subcutaneous tissue disorders Skin ulcer	0.34% 1/290 • Up to 6 months FAS population
Surgical and medical procedures Knee arthroplasty	0.34% 1/290 • Up to 6 months FAS population
Vascular disorders Embolism	0.34% 1/290 • Up to 6 months FAS population
Vascular disorders Thrombosis	0.34% 1/290 • Up to 6 months FAS population

Other adverse events

Measure	Rheumatoid Arthritis Participants n=290 participants at risk Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
Gastrointestinal disorders Abdominal pain	0.34% 1/290 • Up to 6 months FAS population
Gastrointestinal disorders Abdominal pain lower	0.34% 1/290 • Up to 6 months FAS population
Gastrointestinal disorders Diarrhoea	1.4% 4/290 • Up to 6 months FAS population
Gastrointestinal disorders Stomatitis	0.34% 1/290 • Up to 6 months FAS population
Gastrointestinal disorders Vomiting	0.34% 1/290 • Up to 6 months FAS population
Blood and lymphatic system disorders Anaemia	1.7% 5/290 • Up to 6 months FAS population
Blood and lymphatic system disorders Granulocytopenia	0.34% 1/290 • Up to 6 months FAS population
Blood and lymphatic system disorders Leukopenia	3.1% 9/290 • Up to 6 months FAS population
Blood and lymphatic system disorders Neutropenia	2.4% 7/290 • Up to 6 months FAS population
Blood and lymphatic system disorders Thrombocytopenia	0.34% 1/290 • Up to 6 months FAS population
Cardiac disorders Extrasystoles	0.34% 1/290 • Up to 6 months FAS population
Eye disorders Conjunctival haemorrhage	0.34% 1/290 • Up to 6 months FAS population
General disorders Chest pain	0.34% 1/290 • Up to 6 months FAS population
General disorders Drug ineffective	0.69% 2/290 • Up to 6 months FAS population
General disorders Oedema	0.34% 1/290 • Up to 6 months FAS population
General disorders Oedema peripheral	0.34% 1/290 • Up to 6 months FAS population
General disorders Pyrexia	0.34% 1/290 • Up to 6 months FAS population
Hepatobiliary disorders Hepatobiliary disease	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Acarodermatitis	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Bronchitis	1.4% 4/290 • Up to 6 months FAS population
Infections and infestations Cellulitis	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Cystitis	0.69% 2/290 • Up to 6 months FAS population
Infections and infestations Erysipelas	0.69% 2/290 • Up to 6 months FAS population
Infections and infestations Fungal skin infection	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Furuncle	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Herpes zoster	0.69% 2/290 • Up to 6 months FAS population
Infections and infestations Influenza	3.1% 9/290 • Up to 6 months FAS population
Infections and infestations Oral herpes	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Pharyngitis	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Pneumonia	0.69% 2/290 • Up to 6 months FAS population
Infections and infestations Sinusitis	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Tooth abscess	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Tracheitis	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Upper respiratory tract infection	1.7% 5/290 • Up to 6 months FAS population
Infections and infestations Urinary tract infection	0.34% 1/290 • Up to 6 months FAS population
Infections and infestations Viral infection	0.34% 1/290 • Up to 6 months FAS population
Injury, poisoning and procedural complications Ankle fracture	0.34% 1/290 • Up to 6 months FAS population
Injury, poisoning and procedural complications Foot fracture	0.34% 1/290 • Up to 6 months FAS population
Injury, poisoning and procedural complications Humerus fracture	0.34% 1/290 • Up to 6 months FAS population
Injury, poisoning and procedural complications Wound	0.34% 1/290 • Up to 6 months FAS population
Investigations Alanine aminotransferase increased	1.7% 5/290 • Up to 6 months FAS population
Investigations Aspartate aminotransferase increased	1.7% 5/290 • Up to 6 months FAS population
Investigations Blood cholesterol increased	0.34% 1/290 • Up to 6 months FAS population
Investigations Blood pressure increased	3.1% 9/290 • Up to 6 months FAS population
Investigations Blood triglycerides increased	0.34% 1/290 • Up to 6 months FAS population
Investigations Gamma-glutamyl transferase increased	0.34% 1/290 • Up to 6 months FAS population
Investigations Hepatic enzyme increased	1.7% 5/290 • Up to 6 months FAS population
Investigations Liver function test abnormal	0.34% 1/290 • Up to 6 months FAS population
Investigations Lymphocyte count increased	0.34% 1/290 • Up to 6 months FAS population
Investigations Mycobacterium tuberculosis complex test positive	0.34% 1/290 • Up to 6 months FAS population
Investigations Neutrophil count decreased	1.0% 3/290 • Up to 6 months FAS population
Investigations Platelet count decreased	0.34% 1/290 • Up to 6 months FAS population
Investigations Transaminases increased	1.0% 3/290 • Up to 6 months FAS population
Investigations Weight decreased	0.34% 1/290 • Up to 6 months FAS population
Metabolism and nutrition disorders Hypercholesterolaemia	0.34% 1/290 • Up to 6 months FAS population
Metabolism and nutrition disorders Hyperlipidaemia	2.1% 6/290 • Up to 6 months FAS population
Metabolism and nutrition disorders Hyperuricaemia	0.69% 2/290 • Up to 6 months FAS population
Musculoskeletal and connective tissue disorders Back pain	0.69% 2/290 • Up to 6 months FAS population
Musculoskeletal and connective tissue disorders Osteoarthritis	0.69% 2/290 • Up to 6 months FAS population
Nervous system disorders Cervicobrachial syndrome	0.34% 1/290 • Up to 6 months FAS population
Nervous system disorders Hypotonia	0.34% 1/290 • Up to 6 months FAS population
Nervous system disorders Trigeminal neuralgia	0.34% 1/290 • Up to 6 months FAS population
Renal and urinary disorders Haematuria	0.34% 1/290 • Up to 6 months FAS population
Renal and urinary disorders Renal failure	0.34% 1/290 • Up to 6 months FAS population
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.34% 1/290 • Up to 6 months FAS population
Respiratory, thoracic and mediastinal disorders Cough	0.34% 1/290 • Up to 6 months FAS population
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.69% 2/290 • Up to 6 months FAS population
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.34% 1/290 • Up to 6 months FAS population
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.34% 1/290 • Up to 6 months FAS population
Skin and subcutaneous tissue disorders Erythema	0.34% 1/290 • Up to 6 months FAS population
Skin and subcutaneous tissue disorders Pruritus	1.4% 4/290 • Up to 6 months FAS population
Skin and subcutaneous tissue disorders Psoriasis	0.34% 1/290 • Up to 6 months FAS population
Skin and subcutaneous tissue disorders Rash	0.69% 2/290 • Up to 6 months FAS population
Skin and subcutaneous tissue disorders Rash pruritic	0.34% 1/290 • Up to 6 months FAS population
Skin and subcutaneous tissue disorders Skin lesion	0.34% 1/290 • Up to 6 months FAS population
Skin and subcutaneous tissue disorders Skin ulcer	0.34% 1/290 • Up to 6 months FAS population
Skin and subcutaneous tissue disorders Urticaria	0.69% 2/290 • Up to 6 months FAS population
Surgical and medical procedures Cholecystectomy	0.34% 1/290 • Up to 6 months FAS population
Surgical and medical procedures Tooth extraction	1.0% 3/290 • Up to 6 months FAS population
Vascular disorders Hypertension	1.7% 5/290 • Up to 6 months FAS population
Vascular disorders Hypotension	0.34% 1/290 • Up to 6 months FAS population

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

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