Trial Outcomes & Findings for An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy (NCT NCT00973479)
NCT ID: NCT00973479
Last Updated: 2013-12-25
Results Overview
An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 20 percentage improvement in at least 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS), (0 \[no pain\] to 10 \[worst pain\]) b. Participant's global assessment of disease activity by VAS c. Physician's global assessment of disease activity by VAS d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C-reactive protein.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
592 participants
Primary outcome timeframe
Week 14
Results posted on
2013-12-25
Participant Flow
This study evaluated the efficacy and safety of intravenous administration of Golimumab 2mg/kg + methotrexate (MTX) in patients with Active Rheumatoid Arthritis despite treatment with MTX therapy. It was conducted between 14 September 2009 and 08 February 2013 and recruited participants at 92 sites in 13 countries worldwide.
592 participants were randomly allocated to 2 treatment arms. At Week 16 some participants in Placebo arm switched to Golimumab earlier than the rest at Week 24. Thus, the Adverse Events are presented based upon the time when participants began to receive Golimumab in the following manner: Golimumab from Day 0, from Week 16 and from Week 24.
Participant milestones
| Measure |
Group I: Placebo + Methotrexate (MTX)
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a \< 10% improvement in both tender and swollen joint count.
|
Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
|
|---|---|---|
|
Overall Study
STARTED
|
197
|
395
|
|
Overall Study
COMPLETED
|
160
|
326
|
|
Overall Study
NOT COMPLETED
|
37
|
69
|
Reasons for withdrawal
| Measure |
Group I: Placebo + Methotrexate (MTX)
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a \< 10% improvement in both tender and swollen joint count.
|
Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
15
|
16
|
|
Overall Study
Lack of Efficacy
|
5
|
7
|
|
Overall Study
Adverse Event
|
12
|
32
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Other
|
1
|
7
|
Baseline Characteristics
An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy
Baseline characteristics by cohort
| Measure |
Group I: Placebo + Methotrexate (MTX)
n=197 Participants
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a \< 10% improvement in both tender and swollen joint count.
|
Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
n=395 Participants
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
|
Total
n=592 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 11.26 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 12.55 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 12.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=5 Participants
|
326 Participants
n=7 Participants
|
483 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
28 participants
n=5 Participants
|
54 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Columbia
|
12 participants
n=5 Participants
|
25 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
10 participants
n=5 Participants
|
21 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
4 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
20 participants
n=5 Participants
|
44 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
8 participants
n=5 Participants
|
18 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
13 participants
n=5 Participants
|
25 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
36 participants
n=5 Participants
|
65 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
23 participants
n=5 Participants
|
46 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
32 participants
n=5 Participants
|
58 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
17 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 14Population: Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.
An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 20 percentage improvement in at least 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS), (0 \[no pain\] to 10 \[worst pain\]) b. Participant's global assessment of disease activity by VAS c. Physician's global assessment of disease activity by VAS d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C-reactive protein.
Outcome measures
| Measure |
Group I: Placebo + Methotrexate (MTX)
n=197 Participants
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a \< 10% improvement in both tender and swollen joint count.
|
Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
n=395 Participants
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
|
|---|---|---|
|
Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14
|
24.9 Percentage of Participants
|
58.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 14Population: Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.
DAS28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis combining tender joints (28 joints), swollen joints (28 joints), CRP, and participant's global assessment of disease activity. The DAS28 score ranges from 0 (best) to 10 (worst). DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Higher scores indicate worsening. A decrease in DAS28 score \>1.2 is being referred to as a "good response" and a decrease of 0.6-1.2 as a "moderate response".
Outcome measures
| Measure |
Group I: Placebo + Methotrexate (MTX)
n=197 Participants
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a \< 10% improvement in both tender and swollen joint count.
|
Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
n=395 Participants
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
|
|---|---|---|
|
Proportion of Participants With Moderate or Good Response in Disease Activity Index Score 28 (DAS28) Using C-reactive Protein (CRP) at Week 14
|
40.1 Percentage of Participants
|
81.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 14Population: Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.
The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). HAQscore on a scale ranges from 0 (no disability) to 3 (completely disabled). Higher scores indicate worsening.
Outcome measures
| Measure |
Group I: Placebo + Methotrexate (MTX)
n=197 Participants
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a \< 10% improvement in both tender and swollen joint count.
|
Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
n=395 Participants
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
|
|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14
|
0.1250 Scores on a scale
Standard Deviation 0.55770
|
0.5000 Scores on a scale
Standard Deviation 0.57706
|
SECONDARY outcome
Timeframe: Week 24Population: Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.
An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm) b. Participant's global assessment of disease activity by VAS (0-10 cm) c. Physician's global assessment of disease activity by VAS (0-10 cm) d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.
Outcome measures
| Measure |
Group I: Placebo + Methotrexate (MTX)
n=197 Participants
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a \< 10% improvement in both tender and swollen joint count.
|
Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
n=395 Participants
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
|
|---|---|---|
|
Proportion of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24
|
13.2 Percentage of Participants
|
34.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.
Total vdH-S score is sum of joint erosion score and joint-space narrowing (JSN) score. Joint erosion score summarizes erosion severity in 32 joints of hands and 12 joints of feet. Each joint scored from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Maximal erosion score is 280. JSN score summarizes severity of JSN in 30 joints of hands and 12 joints of feet. Assessment of JSN, including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). Maximal JSN score is 168. Thus, the worst possible vdH-S score is 448.
Outcome measures
| Measure |
Group I: Placebo + Methotrexate (MTX)
n=197 Participants
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a \< 10% improvement in both tender and swollen joint count.
|
Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
n=395 Participants
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
|
|---|---|---|
|
Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24.
|
1.09 Scores on a scale
Standard Deviation 3.194
|
0.03 Scores on a scale
Standard Deviation 1.899
|
Adverse Events
Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16
Serious events: 11 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24
Serious events: 17 serious events
Other events: 38 other events
Deaths: 0 deaths
Golimumab 2 mg/kg + MTX
Serious events: 78 serious events
Other events: 199 other events
Deaths: 0 deaths
Combined Golimumab
Serious events: 106 serious events
Other events: 271 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16
n=68 participants at risk
Participants received placebo only through Week 16 and met early escape criteria or subjects who received first placebo and later inadvertently received Golimumab prior or at Week 16. The follow-up period for this treatment group begins once a participant switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
|
Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24
n=121 participants at risk
Participants received placebo only through Week 24 or subjects who received first placebo and later inadvertently received Golimumab after Week 16 through Week 24. The follow-up period for this treatment group begins once a participants switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
|
Golimumab 2 mg/kg + MTX
n=395 participants at risk
Participants were assigned to Golimumab 2 mg/kg + MTX and received at least one 2 mg/kg Golimumab. The follow-up period for this treatment group begins with the first dose of Golimumab 2 mg/kg. Participants may have missed one or more Golimumab doses.
|
Combined Golimumab
n=584 participants at risk
Participants in the reporting groups: Placebo + MTX -\> Golimumab 2 mg/kg + MTX at Week 16, Placebo + MTX -\> Golimumab 2 mg/kg + MTX at Week 24, and Golimumab 2 mg/kg + MTX.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Angina pectoris
|
1.5%
1/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.34%
2/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.34%
2/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
1/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.34%
2/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.51%
2/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.51%
3/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Sick sinus syndrome
|
1.5%
1/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Eye disorders
Cataract
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.76%
3/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.51%
3/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
General disorders
Cyst
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
General disorders
Pyrexia
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
General disorders
Sudden death
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Device related infection
|
1.5%
1/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Empyema
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Endophthalmitis
|
1.5%
1/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.51%
2/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.34%
2/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Infective spondylitis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.0%
4/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.86%
5/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Septic shock
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.76%
3/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.68%
4/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Concussion
|
1.5%
1/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
1/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
1.5%
1/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.34%
2/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.5%
1/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.51%
2/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.51%
3/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
1/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.51%
3/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
2.9%
2/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.5%
10/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.1%
12/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.34%
2/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Iiird nerve paresis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.51%
2/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.34%
2/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Syncope
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Reproductive system and breast disorders
Bartholinitis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Reproductive system and breast disorders
Breast disorder
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.51%
2/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.34%
2/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.83%
1/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Vascular disorders
Hypotension
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.25%
1/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.17%
1/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
Other adverse events
| Measure |
Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16
n=68 participants at risk
Participants received placebo only through Week 16 and met early escape criteria or subjects who received first placebo and later inadvertently received Golimumab prior or at Week 16. The follow-up period for this treatment group begins once a participant switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
|
Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24
n=121 participants at risk
Participants received placebo only through Week 24 or subjects who received first placebo and later inadvertently received Golimumab after Week 16 through Week 24. The follow-up period for this treatment group begins once a participants switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
|
Golimumab 2 mg/kg + MTX
n=395 participants at risk
Participants were assigned to Golimumab 2 mg/kg + MTX and received at least one 2 mg/kg Golimumab. The follow-up period for this treatment group begins with the first dose of Golimumab 2 mg/kg. Participants may have missed one or more Golimumab doses.
|
Combined Golimumab
n=584 participants at risk
Participants in the reporting groups: Placebo + MTX -\> Golimumab 2 mg/kg + MTX at Week 16, Placebo + MTX -\> Golimumab 2 mg/kg + MTX at Week 24, and Golimumab 2 mg/kg + MTX.
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
8.8%
6/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.4%
9/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
9.4%
37/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
8.9%
52/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
3/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.6%
8/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.1%
28/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.7%
39/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.8%
7/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.6%
26/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.7%
33/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
5/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.6%
8/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
13.7%
54/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
11.5%
67/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Urinary tract infection
|
4.4%
3/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.8%
7/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.6%
26/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.2%
36/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
8/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.5%
3/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.8%
27/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.5%
38/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
5/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.7%
2/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.6%
18/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.3%
25/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Investigations
Hepatic enzyme increased
|
5.9%
4/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.5%
6/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.7%
10/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
13.2%
9/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.5%
3/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
8.4%
33/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.7%
45/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Headache
|
7.4%
5/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.7%
2/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.8%
27/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.8%
34/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Vascular disorders
Hypertension
|
11.8%
8/68 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
4/121 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.8%
27/395 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.7%
39/584 • Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
Additional Information
Director Clinical Research
Centocor, Inc.
Phone: 1-800-457-6399
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60