Trial Outcomes & Findings for A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies (NCT NCT02097745)
NCT ID: NCT02097745
Last Updated: 2016-11-03
Results Overview
A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in tender and swollen joint counts (28 assessed joints) and 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, left end=no disease activity \[symptom-free and no arthritis symptoms\], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); 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 acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). The ACR20 response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
341 participants
Primary outcome timeframe
Baseline to the end of the retreatment period (up to 7 years, 6 months)
Results posted on
2016-11-03
Participant Flow
Participant milestones
| Measure |
Rituximab
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
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|---|---|
|
Overall Study
STARTED
|
335
|
|
Overall Study
COMPLETED
|
157
|
|
Overall Study
NOT COMPLETED
|
178
|
Reasons for withdrawal
| Measure |
Rituximab
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
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|---|---|
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Overall Study
Adverse Event
|
25
|
|
Overall Study
Death
|
16
|
|
Overall Study
Failure to Return
|
14
|
|
Overall Study
Administrative/Other
|
27
|
|
Overall Study
Reason Not Specified
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96
|
Baseline Characteristics
A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies
Baseline characteristics by cohort
| Measure |
Rituximab
n=335 Participants
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
273 Participants
n=5 Participants
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|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of the retreatment period (up to 7 years, 6 months)Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.
A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in tender and swollen joint counts (28 assessed joints) and 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, left end=no disease activity \[symptom-free and no arthritis symptoms\], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); 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 acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). The ACR20 response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.
Outcome measures
| Measure |
Placebo
n=335 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
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|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response
Retreatment 3 (n = 234)
|
73.9 Percentage of participants
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response
Retreatment 4 (n = 175)
|
67.4 Percentage of participants
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response
Retreatment 5 (n = 136)
|
69.9 Percentage of participants
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response
Retreatment 6 (n = 92)
|
72.8 Percentage of participants
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response
Retreatment 1 (n = 320)
|
67.5 Percentage of participants
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response
Retreatment 2 (n = 267)
|
74.9 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to the end of the retreatment period (up to 7 years, 6 months)Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.
The DAS28 is an index for measuring disease activity in rheumatic arthritis 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 represents higher disease activity. A negative change score indicates improvement. The first retreatment may have occurred in the precursor study WA17042.
Outcome measures
| Measure |
Placebo
n=335 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
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|---|---|---|
|
Change From Baseline in the Disease Activity Score 28 (DAS28)
Retreatment 1 (n = 304)
|
-2.32 Units on a scale
Standard Deviation 1.336
|
—
|
|
Change From Baseline in the Disease Activity Score 28 (DAS28)
Retreatment 2 (n = 258)
|
-2.77 Units on a scale
Standard Deviation 1.302
|
—
|
|
Change From Baseline in the Disease Activity Score 28 (DAS28)
Retreatment 3 (n = 227)
|
-3.01 Units on a scale
Standard Deviation 1.388
|
—
|
|
Change From Baseline in the Disease Activity Score 28 (DAS28)
Retreatment 4 (n = 168)
|
-3.05 Units on a scale
Standard Deviation 1.537
|
—
|
|
Change From Baseline in the Disease Activity Score 28 (DAS28)
Retreatment 5 (n = 132)
|
-3.15 Units on a scale
Standard Deviation 1.536
|
—
|
|
Change From Baseline in the Disease Activity Score 28 (DAS28)
Retreatment 6 (n = 87)
|
-2.96 Units on a scale
Standard Deviation 1.540
|
—
|
SECONDARY outcome
Timeframe: Baseline to the end of the retreatment period (up to 7 years, 6 months)Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.
The DAS28 is an index for measuring disease activity in rheumatic arthritis 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 higher scores represent higher disease activity. Low disease activity was defined as a DAS28 score ≤ 3.2. DAS28 remission was defined as a DAS28 score \< 2.6. The first retreatment may have occurred in the precursor study WA17042.
Outcome measures
| Measure |
Placebo
n=335 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
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|---|---|---|
|
Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
Retreatment 1: Low Disease Activity (n=314)
|
17.2 Percentage of participants
|
—
|
|
Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
Retreatment 1: Remission
|
8.9 Percentage of participants
|
—
|
|
Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
Retreatment 2: Low Disease Activity (n=265)
|
27.9 Percentage of participants
|
—
|
|
Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
Retreatment 2: Remission
|
15.1 Percentage of participants
|
—
|
|
Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
Retreatment 3: Low Disease Activity (n=234)
|
36.8 Percentage of participants
|
—
|
|
Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
Retreatment 3: Remission
|
18.8 Percentage of participants
|
—
|
|
Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
Retreatment 4: Low Disease Activity (n=172)
|
33.7 Percentage of participants
|
—
|
|
Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
Retreatment 4: Remission
|
20.9 Percentage of participants
|
—
|
|
Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
Retreatment 5: Low Disease Activity (n=135)
|
36.3 Percentage of participants
|
—
|
|
Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
Retreatment 5: Remission
|
20.0 Percentage of participants
|
—
|
|
Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
Retreatment 6: Low Disease Activity (n=90)
|
33.3 Percentage of participants
|
—
|
|
Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
Retreatment 6: Remission
|
15.6 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to the end of the retreatment period (up to 7 years, 6 months)Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.
Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \< -1.2 was a good response, \< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \> 3.2 to ≤ 5.1, a change from baseline of \< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \> 5.1, a change from baseline \< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \> 3.2. The first retreatment may have occurred in the precursor study WA17042.
Outcome measures
| Measure |
Placebo
n=335 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|---|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 1: Good Response (n = 304)
|
17.1 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 1: Moderate Response
|
64.8 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 1: No Response
|
18.1 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 2: Good Response (n = 258)
|
27.5 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 2: Moderate Response
|
64.3 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 2: No Response
|
8.1 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 3: Good Response (n = 227)
|
36.6 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 3: Moderate Response
|
53.3 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 3: No Response
|
10.1 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 4: Good Response (n = 168)
|
33.9 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 4: Moderate Response
|
58.9 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 4: No Response
|
7.1 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 5: Good Response (n = 132)
|
36.4 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 5: Moderate Response
|
54.5 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 5: No Response
|
9.1 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 6: Good Response (n = 87)
|
33.3 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 6: Moderate Response
|
59.8 Percentage of participants
|
—
|
|
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
Retreatment 6: No Response
|
6.9 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to the end of the retreatment period (up to 7 years, 6 months)Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.
The ACRn response was defined as each participant's least favorable percentage change from Baseline in 3 measures, tender joint count, swollen joint count (28 assessed joints), and improvement score achieved in at least 3 of the 5 remaining ACR parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity, right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain, right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). A higher change percentage indicates greater improvement from Baseline. The ACRn response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.
Outcome measures
| Measure |
Placebo
n=335 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|---|
|
Change From Baseline in the American College of Rheumatology n (ACRn) Response
Retreatment 1 (n = 320)
|
32.04 Percentage change
Standard Deviation 37.709
|
—
|
|
Change From Baseline in the American College of Rheumatology n (ACRn) Response
Retreatment 2 (n = 267)
|
39.25 Percentage change
Standard Deviation 35.494
|
—
|
|
Change From Baseline in the American College of Rheumatology n (ACRn) Response
Retreatment 3 (n = 234)
|
39.89 Percentage change
Standard Deviation 41.166
|
—
|
|
Change From Baseline in the American College of Rheumatology n (ACRn) Response
Retreatment 4 (n = 175)
|
37.71 Percentage change
Standard Deviation 43.201
|
—
|
|
Change From Baseline in the American College of Rheumatology n (ACRn) Response
Retreatment 5 (n = 136)
|
37.59 Percentage change
Standard Deviation 41.109
|
—
|
|
Change From Baseline in the American College of Rheumatology n (ACRn) Response
Retreatment 6 (n = 92)
|
35.53 Percentage change
Standard Deviation 38.650
|
—
|
SECONDARY outcome
Timeframe: Baseline to the end of the retreatment period (up to 7 years, 6 months)Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.
The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo
n=335 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|---|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Retreatment 1 (n = 320)
|
-0.51 Units on a scale
Standard Deviation 0.569
|
—
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Retreatment 2 (n = 267)
|
-0.54 Units on a scale
Standard Deviation 0.569
|
—
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Retreatment 3 (n = 234)
|
-0.56 Units on a scale
Standard Deviation 0.601
|
—
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Retreatment 4 (n = 175)
|
-0.55 Units on a scale
Standard Deviation 0.603
|
—
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Retreatment 5 (n = 136)
|
-0.60 Units on a scale
Standard Deviation 0.647
|
—
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Retreatment 6 (n = 92)
|
-0.55 Units on a scale
Standard Deviation 0.653
|
—
|
SECONDARY outcome
Timeframe: Baseline to the end of the retreatment period (up to 7 years, 6 months)Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.
The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.
Outcome measures
| Measure |
Placebo
n=335 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|---|
|
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
Retreatment 1: Physical Health (n = 249)
|
7.383 Units on a scale
Standard Deviation 8.4618
|
—
|
|
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
Retreatment 1: Mental Health
|
5.550 Units on a scale
Standard Deviation 12.0705
|
—
|
|
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
Retreatment 2: Physical Health (n = 255)
|
6.018 Units on a scale
Standard Deviation 7.9757
|
—
|
|
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
Retreatment 2: Mental Health
|
5.746 Units on a scale
Standard Deviation 10.7778
|
—
|
|
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
Retreatment 3: Physical Health (n = 220)
|
6.206 Units on a scale
Standard Deviation 8.2326
|
—
|
|
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
Retreatment 3: Mental Health
|
4.777 Units on a scale
Standard Deviation 10.1916
|
—
|
|
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
Retreatment 4: Physical Health (n = 167)
|
5.660 Units on a scale
Standard Deviation 7.9137
|
—
|
|
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
Retreatment 4: Mental Health
|
4.864 Units on a scale
Standard Deviation 10.2215
|
—
|
|
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
Retreatment 5: Physical Health (n = 124)
|
5.038 Units on a scale
Standard Deviation 8.2643
|
—
|
|
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
Retreatment 5: Mental Health
|
5.141 Units on a scale
Standard Deviation 11.8848
|
—
|
|
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
Retreatment 6: Physical Health (n = 88)
|
5.214 Units on a scale
Standard Deviation 7.5370
|
—
|
|
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
Retreatment 6: Mental Health
|
2.658 Units on a scale
Standard Deviation 9.8556
|
—
|
SECONDARY outcome
Timeframe: Baseline to the end of the retreatment period (up to 7 years, 6 months)Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.
The FACIT-F is a 13-item participant self-reporting questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo
n=335 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|---|
|
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
Retreatment 1 (n = 321)
|
10.790 Units on a scale
Standard Deviation 10.7934
|
—
|
|
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
Retreatment 2 (n = 272)
|
6.390 Units on a scale
Standard Deviation 9.1312
|
—
|
|
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
Retreatment 3 (n = 232)
|
7.075 Units on a scale
Standard Deviation 9.8208
|
—
|
|
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
Retreatment 4 (n = 176)
|
6.770 Units on a scale
Standard Deviation 10.4043
|
—
|
|
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
Retreatment 5 (n = 131)
|
8.030 Units on a scale
Standard Deviation 10.4571
|
—
|
|
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
Retreatment 6 (n = 89)
|
5.429 Units on a scale
Standard Deviation 9.4251
|
—
|
SECONDARY outcome
Timeframe: Baseline to Year 5Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.
Radiographic progression was defined as a change of ≤ 0 in the total Genant-modified Sharp score. The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290; the minimum score is 0. A higher score indicates more damage. Data is reported for 2 groups.
Outcome measures
| Measure |
Placebo
n=79 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
n=105 Participants
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|---|
|
Percentage of Participants With no Radiographic Progression From Baseline to Year 5
|
21.5 Percentage of participants
Interval 12.0 to 31.0
|
32.4 Percentage of participants
Interval 23.0 to 41.0
|
SECONDARY outcome
Timeframe: Baseline to Year 5Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.
The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290; the minimum score is 0. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.
Outcome measures
| Measure |
Placebo
n=79 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
n=105 Participants
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|---|
|
Change From Baseline in the Total Genant-modified Sharp Score at Year 5
|
5.446 Units on a scale
Standard Deviation 8.4701
|
3.202 Units on a scale
Standard Deviation 6.5538
|
SECONDARY outcome
Timeframe: Baseline to Year 5Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.
The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140 which is normalized to 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.
Outcome measures
| Measure |
Placebo
n=79 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
n=105 Participants
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|---|
|
Change From Baseline in the Genant-modified Sharp Erosion Score at Year 5
|
3.101 Units on a scale
Standard Deviation 4.8980
|
1.880 Units on a scale
Standard Deviation 4.4491
|
SECONDARY outcome
Timeframe: Baseline to Year 5Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.
The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score joint space narrowing of 0-4 (9 gradations) is assigned to 13 joints in each hand and 6 joints in each foot. The maximum joint space narrowing score is 38 x 4.0 = 152 which is normalized to a score of 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.
Outcome measures
| Measure |
Placebo
n=79 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
n=105 Participants
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|---|
|
Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score at Year 5
|
2.344 Units on a scale
Standard Deviation 4.3263
|
1.322 Units on a scale
Standard Deviation 2.7831
|
SECONDARY outcome
Timeframe: Baseline to Year 5Population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.
The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement. Data is reported for 2 groups.
Outcome measures
| Measure |
Placebo
n=75 Participants
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
n=100 Participants
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|---|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Year 5
|
-0.408 Units on a scale
Standard Deviation 0.5348
|
-0.540 Units on a scale
Standard Deviation 0.6521
|
Adverse Events
Placebo
Serious events: 14 serious events
Other events: 112 other events
Deaths: 0 deaths
Rituximab
Serious events: 197 serious events
Other events: 327 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=140 participants at risk
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
n=335 participants at risk
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
3.0%
10/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.8%
6/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.2%
4/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.2%
4/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.2%
4/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Abscess
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Abscess intestinal
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.00%
0/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Cytomegalovirus duodenitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Device related infection
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.00%
0/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Influenza
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Meningitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Scedosporium infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Shigella infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Wound infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Zoonosis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.9%
23/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
3.0%
10/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Hand deformity
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Metabolism and nutrition disorders
Joint instability
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Ligament calcification
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.00%
0/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.00%
0/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.5%
5/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Myocardial infarction
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.2%
4/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.2%
4/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Pericarditis
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Angina unstable
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
3/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
3.9%
13/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.2%
4/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.2%
4/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.2%
4/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Protein-losing gastroenteropathy
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.5%
5/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.2%
4/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oligodendroglioma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Infusion related reaction
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.5%
5/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Pyrexia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.2%
4/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Surgical failure
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Chest pain
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Device failure
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Asthenia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Death
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Device breakage
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Device dislocation
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Device occlusion
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Inflammation
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.2%
4/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Cluster headache
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Vascular disorders
Hypertension
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Vascular disorders
Aortic occlusion
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Vascular disorders
Poor peripheral circulation
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.90%
3/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Reproductive system and breast disorders
Urogenital prolapse
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
1.2%
4/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Renal and urinary disorders
Eosinophilic cystitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Investigations
Respiratory rate decreased
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Social circumstances
Physical assault
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.30%
1/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
0.60%
2/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
Other adverse events
| Measure |
Placebo
n=140 participants at risk
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
Rituximab
n=335 participants at risk
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
14/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
39.4%
132/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
12/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
30.1%
101/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Urinary tract infection
|
7.9%
11/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
25.7%
86/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Bronchitis
|
6.4%
9/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
24.2%
81/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Sinusitis
|
9.3%
13/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
20.3%
68/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
2/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
14.3%
48/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
2/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
13.4%
45/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Influenza
|
1.4%
2/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
12.5%
42/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Cellulitis
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
7.5%
25/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Rhinitis
|
2.1%
3/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.6%
22/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Tooth abscess
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.9%
23/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Oral herpes
|
2.9%
4/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.7%
19/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Pneumonia
|
1.4%
2/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.3%
21/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.6%
22/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Ear infection
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.7%
19/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Herpes zoster
|
2.1%
3/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.1%
17/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.0%
20/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.1%
17/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
40.7%
57/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
64.8%
217/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
6/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
20.3%
68/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
5/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
14.0%
47/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.1%
3/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
11.3%
38/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
9.0%
30/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
9.3%
31/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
2/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.3%
21/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.6%
22/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.6%
22/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.7%
19/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.4%
18/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Infusion related reaction
|
18.6%
26/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
46.3%
155/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Fatigue
|
2.9%
4/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
11.9%
40/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Oedema peripheral
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
12.8%
43/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Pyrexia
|
2.1%
3/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.0%
20/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
General disorders
Influenza like illness
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.1%
17/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
8/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
16.4%
55/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
12/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
13.4%
45/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
3/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
9.3%
31/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
6/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
7.2%
24/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
3/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
7.5%
25/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
7.8%
26/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
2/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.7%
19/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Gastrointestinal disorders
Dental caries
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.0%
20/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
6/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
14.9%
50/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
6/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.6%
22/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
4/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.9%
23/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.7%
19/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.7%
19/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Psychiatric disorders
Depression
|
3.6%
5/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
15.5%
52/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Psychiatric disorders
Insomnia
|
3.6%
5/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
11.9%
40/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Psychiatric disorders
Anxiety
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.4%
18/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Headache
|
5.0%
7/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
18.2%
61/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Dizziness
|
1.4%
2/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
7.5%
25/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.4%
18/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
8/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
14.6%
49/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.7%
19/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.4%
18/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
4/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
21.2%
71/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
10.4%
35/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.1%
3/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
7.5%
25/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.4%
18/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Vascular disorders
Hypertension
|
2.9%
4/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
17.3%
58/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Eye disorders
Cataract
|
0.71%
1/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
6.6%
22/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.7%
19/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
3/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
7.5%
25/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
|
Immune system disorders
Seasonal allergy
|
1.4%
2/140
Safety population: All participants who received any part of an infusion of study medication in this study.
|
5.1%
17/335
Safety population: All participants who received any part of an infusion of study medication in this study.
|
Additional Information
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