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A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM) (FILM)

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ClinicalTrials.gov Identifier: NCT00485589
Recruitment Status : Terminated (Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.)
First Posted : June 13, 2007
Results First Posted : November 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Methotrexate
Drug: Ocrelizumab
Drug: Placebo
Enrollment 613
Recruitment Details  
Pre-assignment Details The study population comprised adult patients with active rheumatoid arthritis (RA) of at least 3 months' but less than 5 years' duration who were naïve to methotrexate. Additionally, patients were required to be naïve to any biologic therapy for RA prior to enrollment.
Arm/Group Title Placebo Ocrelizumab 200 mg Ocrelizumab 500 mg
Hide Arm/Group Description Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone. Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone. Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Period Title: Overall Study
Started 210 200 203
Completed 183 180 185
Not Completed 27 20 18
Reason Not Completed
Death             2             2             0
Failure to return             6             5             1
Protocol Violation             1             0             0
Violation of selection criteria at entry             0             3             1
Administrative/Other             1             2             1
Insufficient therapeutic response             10             3             1
Refused treatment/did not cooperate             1             0             2
Withdrawal by Subject             3             2             2
Adverse Event             3             3             10
Arm/Group Title Placebo Ocrelizumab 200 mg Ocrelizumab 500 mg Total
Hide Arm/Group Description Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone. Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone. Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone. Total of all reporting groups
Overall Number of Baseline Participants 207 196 202 605
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 196 participants 202 participants 605 participants
49.2  (12.43) 50.8  (13.17) 48.6  (12.29) 49.5  (12.66)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 196 participants 202 participants 605 participants
Female 153 154 161 468
Male 54 42 41 137
1.Primary Outcome
Title Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 52
Hide Description The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Ocrelizumab 200 mg Ocrelizumab 500 mg
Hide Arm/Group Description:
Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Overall Number of Participants Analyzed 193 187 194
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.59  (4.815) 0.66  (4.509) 0.27  (2.908)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ocrelizumab 200 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Pre-specified analysis
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Van Elteren's test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ocrelizumab 500 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Pre-specified analysis
Statistical Test of Hypothesis P-Value 0.0033
Comments [Not Specified]
Method Van Elteren's test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Without Radiographic Progression (RP) at Week 52
Hide Description RP was defined as a change from Baseline in the modified Total Sharp Score (mTSS) ≤ 0. The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Ocrelizumab 200 mg Ocrelizumab 500 mg
Hide Arm/Group Description:
Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Overall Number of Participants Analyzed 196 187 192
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
51
(44 to 58)
66.3
(59.5 to 73.1)
68.8
(62.2 to 75.3)
3.Secondary Outcome
Title Percentage of Participants With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Week 52
Hide Description Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "none" [symptom-free and no arthritis symptoms] and the extreme right end "maximum" [maximum arthritis disease activity]; patient assessment of pain in the previous 24 hours on a VAS (extreme left end of the line "none" and the extreme right end "unbearable"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Ocrelizumab 200 mg Ocrelizumab 500 mg
Hide Arm/Group Description:
Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Overall Number of Participants Analyzed 207 196 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
ACR20
57.5
(50.8 to 64.2)
73
(66.7 to 79.2)
71
(64.7 to 77.3)
ACR50
39.6
(33 to 46.3)
60.7
(53.9 to 67.6)
54.5
(47.6 to 61.4)
ACR70
20.3
(14.8 to 25.8)
38.3
(31.5 to 45.1)
38
(31.3 to 44.7)
4.Secondary Outcome
Title Percentage of Participants in Disease Activity Score 28 (DAS28) Remission at Weeks 24 and 52
Hide Description A participant was in DAS28 remission if their DAS28 score < 2.6). The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where a higher score indicates more disease activity.
Time Frame Week 24 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Ocrelizumab 200 mg Ocrelizumab 500 mg
Hide Arm/Group Description:
Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Overall Number of Participants Analyzed 207 196 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 24
9.7
(5.6 to 13.7)
19.9
(14.3 to 25.5)
18
(12.7 to 23.3)
Week 52
7.2
(3.7 to 10.8)
27
(20.8 to 33.3)
28
(21.8 to 34.2)
Time Frame Baseline up to 30 months.
Adverse Event Reporting Description Safety population: All randomized participants who received at least 1 dose of study medication.
 
Arm/Group Title Placebo - Treatment Period Placebo/Ocrelizumab 500 mg - Treatment Period Ocrelizumab 200 mg - Treatment Period Ocrelizumab 200 mg/Ocrelizumab 500 mg - Treatment Period Ocrelizumab 500 mg - Treatment Period Ocrelizumab 500 mg/Ocrelizumab 500 mg - Treatment Period Placebo - Safety Follow-up Period Placebo/Ocrelizumab 500 mg - Safety Follow-up Period Ocrelizumab 200 mg - Safety Follow-up Period Ocrelizumab 200 mg/Ocrelizumab 500 Mg-safety Follow-up Period Ocrelizumab 500 mg - Safety Follow-up Period Ocrelizumab 500 mg/Ocrelizumab 500 mg -Safety Follow-up Period
Hide Arm/Group Description Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone. Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone. Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone. Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone. Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone. Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone. Participants had received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone. Participants had received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone. Participants had received Ocrelizumab intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone. Participants had received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone. Participants had received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone. Participants had received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
All-Cause Mortality
Placebo - Treatment Period Placebo/Ocrelizumab 500 mg - Treatment Period Ocrelizumab 200 mg - Treatment Period Ocrelizumab 200 mg/Ocrelizumab 500 mg - Treatment Period Ocrelizumab 500 mg - Treatment Period Ocrelizumab 500 mg/Ocrelizumab 500 mg - Treatment Period Placebo - Safety Follow-up Period Placebo/Ocrelizumab 500 mg - Safety Follow-up Period Ocrelizumab 200 mg - Safety Follow-up Period Ocrelizumab 200 mg/Ocrelizumab 500 Mg-safety Follow-up Period Ocrelizumab 500 mg - Safety Follow-up Period Ocrelizumab 500 mg/Ocrelizumab 500 mg -Safety Follow-up Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/207 (0.00%)      0/10 (0.00%)      0/196 (0.00%)      0/12 (0.00%)      0/202 (0.00%)      0/6 (0.00%)      2/187 (1.07%)      0/9 (0.00%)      2/177 (1.13%)      0/11 (0.00%)      1/185 (0.54%)      0/6 (0.00%)    
Hide Serious Adverse Events
Placebo - Treatment Period Placebo/Ocrelizumab 500 mg - Treatment Period Ocrelizumab 200 mg - Treatment Period Ocrelizumab 200 mg/Ocrelizumab 500 mg - Treatment Period Ocrelizumab 500 mg - Treatment Period Ocrelizumab 500 mg/Ocrelizumab 500 mg - Treatment Period Placebo - Safety Follow-up Period Placebo/Ocrelizumab 500 mg - Safety Follow-up Period Ocrelizumab 200 mg - Safety Follow-up Period Ocrelizumab 200 mg/Ocrelizumab 500 Mg-safety Follow-up Period Ocrelizumab 500 mg - Safety Follow-up Period Ocrelizumab 500 mg/Ocrelizumab 500 mg -Safety Follow-up Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/207 (10.63%)      0/10 (0.00%)      21/196 (10.71%)      1/12 (8.33%)      31/202 (15.35%)      0/6 (0.00%)      11/187 (5.88%)      2/9 (22.22%)      2/177 (1.13%)      0/11 (0.00%)      4/185 (2.16%)      0/6 (0.00%)    
Blood and lymphatic system disorders                         
Agranulocytosis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Anaemia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Anaemia haemolytic autoimmune  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Neutropenia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Leukopenia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Pancytopenia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Cardiac disorders                         
Acute myocardial infarction  1  1/207 (0.48%)  1 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Coronary artery disease  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Arteriosclerosis coronary artery  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Atrial fibrillation  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Tachycardia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Supraventricular tachycardia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Congenital, familial and genetic disorders                         
Bronchogenic cyst  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Ear and labyrinth disorders                         
Deafness bilateral  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Vestibular disorder  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Endocrine disorders                         
Hyperthyroidism  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0/6 (0.00%)  0
Eye disorders                         
Cataract  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders                         
Inguinal hernia  1  2/207 (0.97%)  2 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Abdominal hernia obstructive  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Constipation  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Gastritis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal haemorrhage  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal inflammation  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Intestinal obstruction  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Colitis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
General disorders                         
Non-cardiac chest pain  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Pyrexia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Hepatobiliary disorders                         
Cholelithiasis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 2/202 (0.99%)  2 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Hepatic cirrhosis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 1/9 (11.11%)  1 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations                         
Urinary tract infection  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 2/202 (0.99%)  4 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Abdominal wall infection  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 1/12 (8.33%)  1 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Abscess  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Acute tonsillitis  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Bacteraemia  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Bronchitis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Bronchopneumonia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Cellulitis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 1/177 (0.56%)  1 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Diverticulitis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%) 
Encephalitis viral  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Histoplasmosis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Infection  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Localised infection  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Pneumonia herpes viral  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Systemic candida  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Sepsis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 1/177 (0.56%)  1 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Oesophageal candidiasis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Peritonitis bacterial  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 1/177 (0.56%)  1 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Pharyngitis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Post procedural infection  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Urosepsis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Pneumonia  1  3/207 (1.45%)  3 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 2/202 (0.99%)  2 0/6 (0.00%)  0 1/187 (0.53%)  1 1/9 (11.11%)  1 2/177 (1.13%)  2 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Injury, poisoning and procedural complications                         
Road traffic accident  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Accidental overdose  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Dislocation of vertebra  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Forearm fracture  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Hip fracture  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Infusion related reaction  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Limb traumatic amputation  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Upper limb fracture  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Joint dislocation  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Lower limb fracture  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Subdural haematoma  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Metabolism and nutrition disorders                         
Hyperglycaemia  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Diabetes mellitus  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 1/177 (0.56%)  1 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Hypoglycaemia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders                         
Rheumatoid arthritis  1  2/207 (0.97%)  2 0/10 (0.00%)  0 2/196 (1.02%)  2 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 2/177 (1.13%)  2 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Osteoarthritis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 2/196 (1.02%)  2 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Back pain  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Osteonecrosis  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                         
Squamous cell carcinoma of skin  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Colon cancer metastatic  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Prostate cancer  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Ovarian fibroma  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders                         
Autonomic neuropathy  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  11 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Carpal tunnel syndrome  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Cerebellar infarction  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Cerebrovascular accident  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Leukoencephalopathy  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Dementia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 1/177 (0.56%)  1 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Ischaemic cerebral infarction  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Psychiatric disorders                         
Depression  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 1/177 (0.56%)  1 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders                         
Nephrolithiasis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Renal failure  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Reproductive system and breast disorders                         
Benign prostatic hyperplasia  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                         
Interstitial lung disease  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 3/202 (1.49%)  3 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Pulmonary alveolar haemorrhage  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Pulmonary eosinophilia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Vocal cord polyp  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Asthma  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Chronic obstructive pulmonary disease  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 1/177 (0.56%)  1 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders                         
Drug reaction with eosinophilia and systemic symptoms  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Pustular psoriasis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Angioedema  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 1/9 (11.11%)  1 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders                         
Aortic aneurysm  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Aortic stenosis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Deep vein thrombosis  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Orthostatic hypotension  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, MeDRA 16.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.05%
Placebo - Treatment Period Placebo/Ocrelizumab 500 mg - Treatment Period Ocrelizumab 200 mg - Treatment Period Ocrelizumab 200 mg/Ocrelizumab 500 mg - Treatment Period Ocrelizumab 500 mg - Treatment Period Ocrelizumab 500 mg/Ocrelizumab 500 mg - Treatment Period Placebo - Safety Follow-up Period Placebo/Ocrelizumab 500 mg - Safety Follow-up Period Ocrelizumab 200 mg - Safety Follow-up Period Ocrelizumab 200 mg/Ocrelizumab 500 Mg-safety Follow-up Period Ocrelizumab 500 mg - Safety Follow-up Period Ocrelizumab 500 mg/Ocrelizumab 500 mg -Safety Follow-up Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   128/207 (61.84%)      4/10 (40.00%)      135/196 (68.88%)      6/12 (50.00%)      144/202 (71.29%)      3/6 (50.00%)      35/187 (18.72%)      3/9 (33.33%)      32/177 (18.08%)      3/11 (27.27%)      49/185 (26.49%)      5/6 (83.33%)    
Blood and lymphatic system disorders                         
Lymphadenopathy  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Neutropenia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Anaemia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 3/177 (1.69%)  3 0/11 (0.00%)  0 2/185 (1.08%)  3 0/6 (0.00%)  0
Eye disorders                         
Conjunctivitis  1  0/207 (0.00%)  0 1/10 (10.00%)  1 0/196 (0.00%)  0 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders                         
Abdominal hernia  1  1/207 (0.48%)  1 0/10 (0.00%)  0 0/196 (0.00%)  0 1/12 (8.33%)  1 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Nausea  1  24/207 (11.59%)  24 0/10 (0.00%)  0 16/196 (8.16%)  16 0/12 (0.00%)  0 22/202 (10.89%)  22 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Diarrhoea  1  14/207 (6.76%)  14 0/10 (0.00%)  0 7/196 (3.57%)  7 0/12 (0.00%)  0 14/202 (6.93%)  14 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 3/177 (1.69%)  3 1/11 (9.09%)  1 3/185 (1.62%)  3 0/6 (0.00%)  0
Dyspepsia  1  14/207 (6.76%)  14 0/10 (0.00%)  0 8/196 (4.08%)  8 0/12 (0.00%)  0 13/202 (6.44%)  13 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Abdominal distension  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Gastric ulcer  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  1/11 (9.09%)  1 0/185 (0.00%)  0 0/6 (0.00%)  0
Gastritis atrophic  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 1/11 (9.09%)  1 0/185 (0.00%)  0 0/6 (0.00%)  0
General disorders                         
Oedema  1  2/207 (0.97%)  2 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 1/6 (16.67%)  1 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Hepatobiliary disorders                         
Drug-induced liver injury  1  18/207 (8.70%)  18 0/10 (0.00%)  0 28/196 (14.29%)  28 0/12 (0.00%)  0 27/202 (13.37%)  27 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations                         
Upper respiratory tract infection  1  36/207 (17.39%)  45 0/10 (0.00%)  0 31/196 (15.82%)  38 0/12 (0.00%)  0 23/202 (11.39%)  29 1/6 (16.67%)  1 7/187 (3.74%)  7 1/9 (11.11%)  1 3/177 (1.69%)  3 2/11 (18.18%)  3 7/185 (3.78%)  7 0/6 (0.00%)  0
Cystitis  1  3/207 (1.45%)  4 0/10 (0.00%)  0 4/196 (2.04%)  6 0/12 (0.00%)  0 4/202 (1.98%)  4 1/6 (16.67%)  1 1/187 (0.53%)  1 0/9 (0.00%)  0 1/177 (0.56%)  1 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Tooth infection  1  1/207 (0.48%)  1 1/10 (10.00%)  1 1/196 (0.51%)  1 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Bronchitis  1  21/207 (10.14%)  21 0/10 (0.00%)  0 22/196 (11.22%)  22 0/12 (0.00%)  0 15/202 (7.43%)  15 0/6 (0.00%)  0 3/187 (1.60%)  3 1/9 (11.11%)  1 5/177 (2.82%)  5 0/11 (0.00%)  0 3/185 (1.62%)  5 0/6 (0.00%)  0
Urinary tract infection  1  12/207 (5.80%)  12 0/10 (0.00%)  0 21/196 (10.71%)  21 0/12 (0.00%)  0 25/202 (12.38%)  25 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 5/177 (2.82%)  5 0/11 (0.00%)  0 12/185 (6.49%)  12 0/6 (0.00%)  0
Nasopharyngitis  1  11/207 (5.31%)  11 0/10 (0.00%)  0 18/196 (9.18%)  18 0/12 (0.00%)  0 16/202 (7.92%)  16 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Sinusitis  1  10/207 (4.83%)  10 0/10 (0.00%)  0 7/196 (3.57%)  7 0/12 (0.00%)  0 15/202 (7.43%)  15 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Gastroenteritis  1  9/207 (4.35%)  9 0/10 (0.00%)  0 10/196 (5.10%)  10 0/12 (0.00%)  0 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Cellulitis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 1/177 (0.56%)  1 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Influenza  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 2/187 (1.07%)  2 1/9 (11.11%)  1 1/177 (0.56%)  1 1/11 (9.09%)  1 3/185 (1.62%)  4 0/6 (0.00%)  0
Tinea versicolour  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 2/185 (1.08%)  2 0/6 (0.00%)  0
Fungal skin infection  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Lower respiratory tract infection  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Sinusitis bacterial  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 1/9 (11.11%)  1 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications                         
Infusion related reaction  1  21/207 (10.14%)  36 4/10 (40.00%)  4 56/196 (28.57%)  79 0/12 (0.00%)  0 64/202 (31.68%)  91 1/6 (16.67%)  1 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Meniscus injury  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 2/187 (1.07%)  2 0/9 (0.00%)  0 1/177 (0.56%)  1 1/11 (9.09%)  1 0/185 (0.00%)  0 0/6 (0.00%)  0
Limb injury  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 1/11 (9.09%)  1 0/185 (0.00%)  0 0/6 (0.00%)  0
Muscle strain  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 1/9 (11.11%)  1 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Foot fracture  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 1/11 (9.09%)  1 0/185 (0.00%)  0 0/6 (0.00%)  0
Investigations                         
Liver function test abnormal  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 1/12 (8.33%)  1 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Blood creatine phosphokinase increased  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 1/9 (11.11%)  1 1/177 (0.56%)  1 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders                         
Hyperlipidaemia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Vitamin D deficiency  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 1/6 (16.67%)  1
Dyslipidaemia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 1/177 (0.56%)  1 0/11 (0.00%)  0 1/185 (0.54%)  1 1/6 (16.67%)  1
Hypocalcaemia  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 1/9 (11.11%)  1 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders                         
Periarthritis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 1/196 (0.51%)  1 1/12 (8.33%)  1 1/202 (0.50%)  1 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Back pain  1  9/207 (4.35%)  9 0/10 (0.00%)  0 10/196 (5.10%)  10 0/12 (0.00%)  0 7/202 (3.47%)  7 0/6 (0.00%)  0 4/187 (2.14%)  4 1/9 (11.11%)  1 2/177 (1.13%)  2 0/11 (0.00%)  0 6/185 (3.24%)  7 0/6 (0.00%)  0
Osteoarthritis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 1/177 (0.56%)  1 1/11 (9.09%)  1 2/185 (1.08%)  2 0/6 (0.00%)  0
Tenosynovitis stenosans  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 1/9 (11.11%)  1 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                         
Thyroid neoplasm  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders                         
Headache  1  13/207 (6.28%)  13 0/10 (0.00%)  0 12/196 (6.12%)  12 0/12 (0.00%)  0 7/202 (3.47%)  7 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Psychiatric disorders                         
Anxiety  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 1/9 (11.11%)  1 0/177 (0.00%)  0 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                         
Wheezing  1  0/207 (0.00%)  0 1/10 (10.00%)  1 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Cough  1  0/207 (0.00%)  0/10 (0.00%)  0/196 (0.00%)  0/12 (0.00%)  0/202 (0.00%)  0/6 (0.00%)  2/187 (1.07%)  2 1/9 (11.11%)  1 2/177 (1.13%)  2 0/11 (0.00%)  0 1/185 (0.54%)  1 0/6 (0.00%)  0
Sinusitis noninfective  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 1/6 (16.67%)  1
Skin and subcutaneous tissue disorders                         
Dry skin  1  2/207 (0.97%)  3 0/10 (0.00%)  0 1/196 (0.51%)  1 1/12 (8.33%)  1 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Erythema  1  0/207 (0.00%)  0 1/10 (10.00%)  1 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Rosacea  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 1/12 (8.33%)  1 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Exfoliative rash  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Rash  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 1/187 (0.53%)  1 0/9 (0.00%)  0 2/177 (1.13%)  2 1/11 (9.09%)  1 1/185 (0.54%)  1 0/6 (0.00%)  0
Dermatitis contact  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 2/187 (1.07%)  2 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 1/6 (16.67%)  1
Angioedema  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 1/9 (11.11%)  1 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Onychoclasis  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 1/11 (9.09%)  1 0/185 (0.00%)  0 0/6 (0.00%)  0
Pruritus  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 1/9 (11.11%)  1 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Surgical and medical procedures                         
Hip arthroplasty  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 1/12 (8.33%)  2 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
Bunion operation  1  0/207 (0.00%)  0 0/10 (0.00%)  0 0/196 (0.00%)  0 0/12 (0.00%)  0 0/202 (0.00%)  0 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 1/6 (16.67%)  1
Vascular disorders                         
Hypertension  1  23/207 (11.11%)  23 0/10 (0.00%)  0 14/196 (7.14%)  14 0/12 (0.00%)  0 18/202 (8.91%)  18 0/6 (0.00%)  0 0/187 (0.00%)  0 0/9 (0.00%)  0 0/177 (0.00%)  0 0/11 (0.00%)  0 0/185 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, MeDRA 16.0
Indicates events were collected by systematic assessment
The study was terminated prematurely by the sponsors before all patients could reach the time point for primary analysis at Week 104. No patient received any further infusions of study medication.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: F. Hoffmann-La Roche AG
Phone: 41 616878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00485589    
Other Study ID Numbers: ACT3984g
WA20497
First Submitted: June 11, 2007
First Posted: June 13, 2007
Results First Submitted: August 27, 2020
Results First Posted: November 3, 2020
Last Update Posted: November 3, 2020