Trial Outcomes & Findings for Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee (NCT NCT02697773)
NCT ID: NCT02697773
Last Updated: 2021-05-03
Results Overview
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
698 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2021-05-03
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5/5 mg
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
|---|---|---|---|
|
Overall Study
STARTED
|
233
|
232
|
233
|
|
Overall Study
Treated
|
232
|
231
|
233
|
|
Overall Study
COMPLETED
|
195
|
194
|
193
|
|
Overall Study
NOT COMPLETED
|
38
|
38
|
40
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5/5 mg
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
|
Overall Study
Death
|
0
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
4
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
7
|
|
Overall Study
Other
|
15
|
11
|
10
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
13
|
13
|
|
Overall Study
Randomized but not treated
|
1
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee
Baseline characteristics by cohort
| Measure |
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5mg/5mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Tanezumab 5 mg injection administered subcutaneously on Week 8.
|
Total
n=696 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
60.83 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
453 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
243 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
196 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
577 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
156 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
504 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
60 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
|
-3.37 units on a scale
Standard Error 0.22
|
-2.64 units on a scale
Standard Error 0.23
|
-3.23 units on a scale
Standard Error 0.23
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
|
-3.45 units on a scale
Standard Error 0.22
|
-2.56 units on a scale
Standard Error 0.22
|
-3.22 units on a scale
Standard Error 0.22
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: The intent to treat population was defined as all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16
|
-0.90 units on a scale
Standard Error 0.08
|
-0.65 units on a scale
Standard Error 0.08
|
-0.87 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12
Change at Week 2
|
-2.89 units on a scale
Standard Error 0.21
|
-2.20 units on a scale
Standard Error 0.21
|
-2.87 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12
Change at Week 4
|
-3.27 units on a scale
Standard Error 0.21
|
-2.40 units on a scale
Standard Error 0.21
|
-3.28 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12
Change at Week 8
|
-3.02 units on a scale
Standard Error 0.21
|
-2.61 units on a scale
Standard Error 0.21
|
-3.20 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12
Change at Week 12
|
-3.69 units on a scale
Standard Error 0.22
|
-2.83 units on a scale
Standard Error 0.23
|
-3.61 units on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24
Baseline
|
7.33 units on a scale
Standard Deviation 1.26
|
7.30 units on a scale
Standard Deviation 1.15
|
7.08 units on a scale
Standard Deviation 1.16
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24
Change at Week 24
|
-2.95 units on a scale
Standard Deviation 2.49
|
-3.07 units on a scale
Standard Deviation 2.43
|
-2.80 units on a scale
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12
Change at Week 12
|
-3.80 units on a scale
Standard Error 0.22
|
-2.75 units on a scale
Standard Error 0.22
|
-3.61 units on a scale
Standard Error 0.22
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12
Change at Week 2
|
-3.05 units on a scale
Standard Error 0.21
|
-2.14 units on a scale
Standard Error 0.21
|
-2.89 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12
Change at Week 4
|
-3.38 units on a scale
Standard Error 0.21
|
-2.28 units on a scale
Standard Error 0.21
|
-3.30 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12
Change at Week 8
|
-3.12 units on a scale
Standard Error 0.21
|
-2.55 units on a scale
Standard Error 0.21
|
-3.17 units on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated maximum difficulty/worse physical function.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24
Change at Week 24
|
-3.01 units on a scale
Standard Deviation 2.46
|
-3.03 units on a scale
Standard Deviation 2.37
|
-2.85 units on a scale
Standard Deviation 2.51
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24
Baseline
|
7.39 units on a scale
Standard Deviation 1.18
|
7.38 units on a scale
Standard Deviation 1.12
|
7.18 units on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities).
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12
Change at Week 12
|
-1.11 units on a scale
Standard Error 0.08
|
-0.83 units on a scale
Standard Error 0.08
|
-1.01 units on a scale
Standard Error 0.08
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12
Change at Week 2
|
-0.87 units on a scale
Standard Error 0.07
|
-0.74 units on a scale
Standard Error 0.07
|
-0.91 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12
Change at Week 4
|
-0.97 units on a scale
Standard Error 0.07
|
-0.75 units on a scale
Standard Error 0.07
|
-1.01 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12
Change at Week 8
|
-0.91 units on a scale
Standard Error 0.07
|
-0.82 units on a scale
Standard Error 0.07
|
-0.97 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24
Change at Week 24
|
-0.91 units on a scale
Standard Deviation 1.03
|
-0.87 units on a scale
Standard Deviation 0.85
|
-0.72 units on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24
Baseline
|
3.53 units on a scale
Standard Deviation 0.62
|
3.46 units on a scale
Standard Deviation 0.57
|
3.42 units on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16 and 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was greater than or equal to (\>=) 50 percent and greater or equal to (\>=) 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and PGA of osteoarthritis (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
Week 2
|
67.4 percentage of participants
|
50.4 percentage of participants
|
65.4 percentage of participants
|
|
Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
Week 4
|
74.7 percentage of participants
|
58.6 percentage of participants
|
74.0 percentage of participants
|
|
Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
Week 8
|
69.5 percentage of participants
|
61.6 percentage of participants
|
67.5 percentage of participants
|
|
Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
Week 12
|
81.1 percentage of participants
|
66.4 percentage of participants
|
77.5 percentage of participants
|
|
Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
Week 16
|
79.0 percentage of participants
|
65.1 percentage of participants
|
72.7 percentage of participants
|
|
Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
Week 24
|
68.8 percentage of participants
|
68.1 percentage of participants
|
66.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16 and 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
Percentage of participants with reduction in WOMAC pain intensity of at least (\>=) 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 12, 16 and 24 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 2: At least 30% reduction
|
56.2 percentage of participants
|
38.8 percentage of participants
|
56.3 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 2: At least 50% reduction
|
38.2 percentage of participants
|
22.8 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 2: At least 70% reduction
|
24.5 percentage of participants
|
15.5 percentage of participants
|
25.5 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 4: At least 50% reduction
|
48.5 percentage of participants
|
30.2 percentage of participants
|
48.5 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 4: At least 70% reduction
|
29.6 percentage of participants
|
16.4 percentage of participants
|
29.4 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 8: At least 30% reduction
|
61.4 percentage of participants
|
49.1 percentage of participants
|
61.9 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 8: At least 50% reduction
|
42.5 percentage of participants
|
30.2 percentage of participants
|
47.2 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 8: At least 90% reduction
|
12.9 percentage of participants
|
9.1 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 16: At least 50% reduction
|
57.1 percentage of participants
|
37.9 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 16: At least 90% reduction
|
14.2 percentage of participants
|
9.5 percentage of participants
|
14.7 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 2: At least 90% reduction
|
9.4 percentage of participants
|
6.9 percentage of participants
|
13.4 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 4: At least 30% reduction
|
63.5 percentage of participants
|
47.0 percentage of participants
|
65.4 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 4: At least 90% reduction
|
15.5 percentage of participants
|
8.2 percentage of participants
|
16.0 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 8: At least 70% reduction
|
25.8 percentage of participants
|
17.2 percentage of participants
|
30.3 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 12: At least 30% reduction
|
75.1 percentage of participants
|
54.3 percentage of participants
|
70.1 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 12: At least 50% reduction
|
56.2 percentage of participants
|
40.5 percentage of participants
|
60.2 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 12: At least 70% reduction
|
39.5 percentage of participants
|
24.1 percentage of participants
|
39.8 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 12: At least 90% reduction
|
18.9 percentage of participants
|
9.9 percentage of participants
|
18.6 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 16: At least 30% reduction
|
70.4 percentage of participants
|
54.7 percentage of participants
|
68.0 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 16: At least 70% reduction
|
36.5 percentage of participants
|
25.0 percentage of participants
|
34.6 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 24: At least 30% reduction
|
59.9 percentage of participants
|
60.5 percentage of participants
|
60.5 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 24: At least 50% reduction
|
41.6 percentage of participants
|
39.5 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 24: At least 70% reduction
|
21.3 percentage of participants
|
23.2 percentage of participants
|
21.0 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 24: At least 90% reduction
|
8.9 percentage of participants
|
10.3 percentage of participants
|
10.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0% ; \>= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Week 16 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
>=10%
|
85.4 percentage of participants
|
79.3 percentage of participants
|
81.8 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
>=20%
|
79.0 percentage of participants
|
65.5 percentage of participants
|
74.0 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
>=0%
|
88.4 percentage of participants
|
82.3 percentage of participants
|
87.4 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
>=30%
|
70.4 percentage of participants
|
54.7 percentage of participants
|
68.0 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
>=40%
|
66.1 percentage of participants
|
45.7 percentage of participants
|
63.2 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
>=50%
|
57.1 percentage of participants
|
37.9 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
>=60%
|
44.6 percentage of participants
|
31.5 percentage of participants
|
44.2 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
>=70%
|
36.5 percentage of participants
|
25.0 percentage of participants
|
34.6 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
>=80%
|
27.0 percentage of participants
|
17.2 percentage of participants
|
24.2 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
>=90%
|
14.2 percentage of participants
|
9.5 percentage of participants
|
14.7 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
=100%
|
10.7 percentage of participants
|
3.9 percentage of participants
|
8.2 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16 and 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
Percentage of participants with reduction in WOMAC physical function of at least (\>=) 30%, 50%, 70% and 90% at weeks 2, 4, 8, 12, 16 and 24 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function refers to participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale: 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours,calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 2: At least 70% reduction
|
24.9 percentage of participants
|
12.1 percentage of participants
|
26.4 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 4: At least 70% reduction
|
30.5 percentage of participants
|
15.1 percentage of participants
|
30.3 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 8: At least 70% reduction
|
27.9 percentage of participants
|
16.8 percentage of participants
|
27.3 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 12: At least 30% reduction
|
75.1 percentage of participants
|
53.0 percentage of participants
|
70.1 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 16: At least 50% reduction
|
57.1 percentage of participants
|
36.6 percentage of participants
|
54.1 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 16: At least 70% reduction
|
36.1 percentage of participants
|
22.8 percentage of participants
|
34.2 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 2: At least 30% reduction
|
56.7 percentage of participants
|
35.8 percentage of participants
|
55.8 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 2: At least 50% reduction
|
39.9 percentage of participants
|
23.7 percentage of participants
|
35.1 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 2: At least 90% reduction
|
9.0 percentage of participants
|
5.2 percentage of participants
|
11.3 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 4: At least 30% reduction
|
64.4 percentage of participants
|
45.7 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 4: At least 50% reduction
|
48.5 percentage of participants
|
26.7 percentage of participants
|
48.1 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 4: At least 90% reduction
|
14.6 percentage of participants
|
6.9 percentage of participants
|
13.4 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 8: At least 30% reduction
|
61.8 percentage of participants
|
47.8 percentage of participants
|
58.9 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 8: At least 50% reduction
|
42.5 percentage of participants
|
28.9 percentage of participants
|
47.6 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 8: At least 90% reduction
|
12.9 percentage of participants
|
7.8 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 12: At least 50% reduction
|
56.2 percentage of participants
|
37.9 percentage of participants
|
57.1 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 12: At least 70% reduction
|
39.5 percentage of participants
|
22.0 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 12: At least 90% reduction
|
18.0 percentage of participants
|
9.1 percentage of participants
|
17.7 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 16: At least 30% reduction
|
71.7 percentage of participants
|
54.3 percentage of participants
|
65.8 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 16: At least 90% reduction
|
14.6 percentage of participants
|
10.3 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 24: At least 30% reduction
|
58.4 percentage of participants
|
57.3 percentage of participants
|
58.0 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 24: At least 50% reduction
|
41.6 percentage of participants
|
38.4 percentage of participants
|
36.5 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 24: At least 70% reduction
|
20.8 percentage of participants
|
21.1 percentage of participants
|
22.0 percentage of participants
|
|
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response
Week 24: At least 90% reduction
|
8.4 percentage of participants
|
8.1 percentage of participants
|
10.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale: 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty),higher scores indicate extreme difficulty/worse physical function. Percentage of participants with cumulative reduction (as percent) (greater than 0 %; \>= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC physical function subscale from Baseline to Week 16 were reported. Missing data was imputed using mixed BOCF/LOCF.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
>=30%
|
71.7 percentage of participants
|
54.3 percentage of participants
|
65.8 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
>=50%
|
57.1 percentage of participants
|
36.6 percentage of participants
|
54.1 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
>=80%
|
26.2 percentage of participants
|
15.5 percentage of participants
|
24.7 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
>=90%
|
14.6 percentage of participants
|
10.3 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
>=0%
|
90.6 percentage of participants
|
83.6 percentage of participants
|
89.2 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
>=10%
|
83.3 percentage of participants
|
75.4 percentage of participants
|
81.0 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
>=20%
|
76.8 percentage of participants
|
63.4 percentage of participants
|
72.7 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
>=40%
|
65.7 percentage of participants
|
44.8 percentage of participants
|
60.2 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
>=60%
|
47.6 percentage of participants
|
28.9 percentage of participants
|
45.0 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
>=70%
|
36.1 percentage of participants
|
22.8 percentage of participants
|
34.2 percentage of participants
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
=100%
|
7.3 percentage of participants
|
2.2 percentage of participants
|
6.5 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16 and 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from Baseline in PGA of osteoarthritis were reported. Missing data was imputed using mixed BOCF/LOCF.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis
Week 2
|
22.3 percentage of participants
|
19.8 percentage of participants
|
25.1 percentage of participants
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis
Week 4
|
27.5 percentage of participants
|
20.7 percentage of participants
|
27.7 percentage of participants
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis
Week 8
|
27.9 percentage of participants
|
24.6 percentage of participants
|
26.8 percentage of participants
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis
Week 12
|
39.1 percentage of participants
|
26.7 percentage of participants
|
34.2 percentage of participants
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis
Week 16
|
31.3 percentage of participants
|
22.8 percentage of participants
|
30.3 percentage of participants
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis
Week 24
|
25.7 percentage of participants
|
21.1 percentage of participants
|
21.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
Participants assessed their average pain in the index hip/knee in the past 24 hours using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16
Change at Week 2
|
-2.23 units on a scale
Standard Error 0.19
|
-1.68 units on a scale
Standard Error 0.19
|
-2.32 units on a scale
Standard Error 0.19
|
|
Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16
Change at Week 12
|
-3.33 units on a scale
Standard Error 0.21
|
-2.58 units on a scale
Standard Error 0.21
|
-3.30 units on a scale
Standard Error 0.21
|
|
Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16
Change at Week 1
|
-1.65 units on a scale
Standard Error 0.15
|
-1.27 units on a scale
Standard Error 0.15
|
-1.60 units on a scale
Standard Error 0.15
|
|
Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16
Change at Week 3
|
-2.71 units on a scale
Standard Error 0.20
|
-1.95 units on a scale
Standard Error 0.20
|
-2.61 units on a scale
Standard Error 0.20
|
|
Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16
Change at Week 4
|
-2.82 units on a scale
Standard Error 0.20
|
-1.88 units on a scale
Standard Error 0.20
|
-2.79 units on a scale
Standard Error 0.20
|
|
Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16
Change at Week 6
|
-2.85 units on a scale
Standard Error 0.21
|
-2.17 units on a scale
Standard Error 0.21
|
-2.89 units on a scale
Standard Error 0.21
|
|
Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16
Change at Week 8
|
-2.70 units on a scale
Standard Error 0.20
|
-2.29 units on a scale
Standard Error 0.21
|
-2.73 units on a scale
Standard Error 0.21
|
|
Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16
Change at Week 10
|
-3.19 units on a scale
Standard Error 0.21
|
-2.51 units on a scale
Standard Error 0.21
|
-3.19 units on a scale
Standard Error 0.21
|
|
Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16
Change at Week 16
|
-3.12 units on a scale
Standard Error 0.22
|
-2.30 units on a scale
Standard Error 0.22
|
-2.98 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline, Weeks 20 and 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Participants assessed their average pain in the index hip/knee in the past 24 hours using a scale ranging from 0 (no pain) to 10 (worst possible pain) weekly beginning at Week 16. Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24
Baseline
|
7.13 units on a scale
Standard Deviation 1.48
|
7.27 units on a scale
Standard Deviation 1.33
|
6.89 units on a scale
Standard Deviation 1.63
|
|
Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24
Change at Week 20
|
-3.26 units on a scale
Standard Deviation 2.65
|
-2.58 units on a scale
Standard Deviation 2.34
|
-2.76 units on a scale
Standard Deviation 2.39
|
|
Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24
Change at Week 24
|
-2.70 units on a scale
Standard Deviation 2.69
|
-2.63 units on a scale
Standard Deviation 2.32
|
-2.14 units on a scale
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12 and 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16
Change at Week 2
|
-2.90 units on a scale
Standard Error 0.21
|
-1.85 units on a scale
Standard Error 0.22
|
-2.90 units on a scale
Standard Error 0.22
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16
Change at Week 8
|
-3.08 units on a scale
Standard Error 0.22
|
-2.34 units on a scale
Standard Error 0.22
|
-3.13 units on a scale
Standard Error 0.22
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16
Change at Week 4
|
-3.27 units on a scale
Standard Error 0.22
|
-2.04 units on a scale
Standard Error 0.22
|
-3.28 units on a scale
Standard Error 0.22
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16
Change at Week 12
|
-3.75 units on a scale
Standard Error 0.23
|
-2.55 units on a scale
Standard Error 0.23
|
-3.59 units on a scale
Standard Error 0.23
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16
Change at Week 16
|
-3.37 units on a scale
Standard Error 0.23
|
-2.38 units on a scale
Standard Error 0.23
|
-3.22 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24
Baseline
|
7.58 units on a scale
Standard Deviation 1.40
|
7.49 units on a scale
Standard Deviation 1.38
|
7.27 units on a scale
Standard Deviation 1.40
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24
Change at Week 24
|
-2.86 units on a scale
Standard Deviation 2.60
|
-2.77 units on a scale
Standard Deviation 2.66
|
-2.74 units on a scale
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12 and 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[no stiffness\] to 10 \[extreme stiffness\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16
Change at Week 4
|
-3.31 units on a scale
Standard Error 0.21
|
-2.24 units on a scale
Standard Error 0.21
|
-3.28 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16
Change at Week 8
|
-3.08 units on a scale
Standard Error 0.21
|
-2.49 units on a scale
Standard Error 0.21
|
-3.17 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16
Change at Week 2
|
-2.95 units on a scale
Standard Error 0.20
|
-2.07 units on a scale
Standard Error 0.21
|
-2.88 units on a scale
Standard Error 0.20
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16
Change at Week 12
|
-3.74 units on a scale
Standard Error 0.22
|
-2.70 units on a scale
Standard Error 0.22
|
-3.59 units on a scale
Standard Error 0.22
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16
Change at Week 16
|
-3.39 units on a scale
Standard Error 0.22
|
-2.53 units on a scale
Standard Error 0.22
|
-3.22 units on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[no stiffness\] to 10 \[extreme stiffness\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 24
Change at Week 24
|
-2.94 units on a scale
Standard Deviation 2.41
|
-2.96 units on a scale
Standard Deviation 2.37
|
-2.80 units on a scale
Standard Deviation 2.48
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 24
Baseline
|
7.44 units on a scale
Standard Deviation 1.17
|
7.39 units on a scale
Standard Deviation 1.11
|
7.18 units on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12 and 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12 and 16
Change at Week 2
|
-2.76 units on a scale
Standard Error 0.21
|
-2.09 units on a scale
Standard Error 0.21
|
-2.75 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12 and 16
Change at Week 4
|
-3.22 units on a scale
Standard Error 0.21
|
-2.31 units on a scale
Standard Error 0.21
|
-3.16 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12 and 16
Change at Week 8
|
-2.89 units on a scale
Standard Error 0.21
|
-2.55 units on a scale
Standard Error 0.21
|
-3.19 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12 and 16
Change at Week 12
|
-3.60 units on a scale
Standard Error 0.23
|
-2.77 units on a scale
Standard Error 0.23
|
-3.53 units on a scale
Standard Error 0.23
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12 and 16
Change at Week 16
|
-3.24 units on a scale
Standard Error 0.23
|
-2.57 units on a scale
Standard Error 0.23
|
-3.17 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 24
Baseline
|
7.24 units on a scale
Standard Deviation 1.42
|
7.22 units on a scale
Standard Deviation 1.39
|
7.03 units on a scale
Standard Deviation 1.40
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 24
Change at Week 24
|
-2.74 units on a scale
Standard Deviation 2.72
|
-2.93 units on a scale
Standard Deviation 2.71
|
-2.64 units on a scale
Standard Deviation 2.69
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12 and 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16
Change at Week 2
|
-3.10 units on a scale
Standard Error 0.22
|
-2.24 units on a scale
Standard Error 0.22
|
-2.88 units on a scale
Standard Error 0.22
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16
Change at Week 12
|
-3.94 units on a scale
Standard Error 0.23
|
-2.97 units on a scale
Standard Error 0.24
|
-3.82 units on a scale
Standard Error 0.24
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16
Change at Week 16
|
-3.59 units on a scale
Standard Error 0.24
|
-2.70 units on a scale
Standard Error 0.24
|
-3.40 units on a scale
Standard Error 0.24
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16
Change at Week 4
|
-3.63 units on a scale
Standard Error 0.22
|
-2.53 units on a scale
Standard Error 0.23
|
-3.50 units on a scale
Standard Error 0.23
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16
Change at Week 8
|
-3.21 units on a scale
Standard Error 0.22
|
-2.77 units on a scale
Standard Error 0.22
|
-3.40 units on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Week 24
Change at Week 24
|
-2.86 units on a scale
Standard Deviation 2.65
|
-3.12 units on a scale
Standard Deviation 2.62
|
-2.76 units on a scale
Standard Deviation 2.52
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Week 24
Baseline
|
8.13 units on a scale
Standard Deviation 1.24
|
8.09 units on a scale
Standard Deviation 1.23
|
7.91 units on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: BaselinePopulation: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
WPAI is 6-question participant rated questionnaire to determine the impact of osteoarthritis on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline
Percent Work Time Missed
|
8.4 units on a scale
Standard Deviation 18.15
|
4.6 units on a scale
Standard Deviation 12.96
|
7.4 units on a scale
Standard Deviation 17.42
|
|
Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline
Percent Overall Work Impairment
|
62.0 units on a scale
Standard Deviation 21.61
|
62.3 units on a scale
Standard Deviation 20.42
|
61.8 units on a scale
Standard Deviation 22.28
|
|
Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline
Percent Impairment While Working
|
60.1 units on a scale
Standard Deviation 21.39
|
60.9 units on a scale
Standard Deviation 19.51
|
59.5 units on a scale
Standard Deviation 21.57
|
|
Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline
Percent Activity Impairment
|
69.8 units on a scale
Standard Deviation 16.00
|
69.4 units on a scale
Standard Deviation 14.62
|
68.3 units on a scale
Standard Deviation 15.56
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
WPAI is 6-question participant rated questionnaire to determine the impact of osteoarthritis on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16
Change at Week 16: Percent Work Time Missed
|
-5.26 units on a scale
Standard Error 1.23
|
-3.58 units on a scale
Standard Error 1.27
|
-2.97 units on a scale
Standard Error 1.17
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16
Change at Week 16:Percent Impairment While Working
|
-27.48 units on a scale
Standard Error 3.39
|
-21.89 units on a scale
Standard Error 3.46
|
-27.32 units on a scale
Standard Error 3.24
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16
Change at Week 16: Percent Activity Impairment
|
-30.49 units on a scale
Standard Error 2.14
|
-26.72 units on a scale
Standard Error 2.18
|
-30.55 units on a scale
Standard Error 2.16
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16
Change at Week 16: Percent Overall Work Impairment
|
-28.87 units on a scale
Standard Error 3.44
|
-22.48 units on a scale
Standard Error 3.52
|
-28.28 units on a scale
Standard Error 3.29
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8 and 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The health utility score for a patient with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a patient reports greater levels of problems across the five dimensions.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Baseline: Mobility
|
3.0 units on a scale
Standard Deviation 0.63
|
3.0 units on a scale
Standard Deviation 0.71
|
3.0 units on a scale
Standard Deviation 0.68
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Baseline: Usual activities
|
3.0 units on a scale
Standard Deviation 0.73
|
2.9 units on a scale
Standard Deviation 0.74
|
3.0 units on a scale
Standard Deviation 0.72
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Baseline: Pain/Discomfort
|
3.4 units on a scale
Standard Deviation 0.73
|
3.3 units on a scale
Standard Deviation 0.73
|
3.4 units on a scale
Standard Deviation 0.68
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Baseline: Anxiety/Depression
|
1.6 units on a scale
Standard Deviation 0.87
|
1.5 units on a scale
Standard Deviation 0.77
|
1.5 units on a scale
Standard Deviation 0.77
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Week 8: Mobility
|
2.2 units on a scale
Standard Deviation 0.84
|
2.3 units on a scale
Standard Deviation 0.84
|
2.1 units on a scale
Standard Deviation 0.86
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Week 8: Pain/Discomfort
|
2.4 units on a scale
Standard Deviation 0.85
|
2.6 units on a scale
Standard Deviation 0.78
|
2.4 units on a scale
Standard Deviation 0.80
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Week 16: Self-care
|
1.5 units on a scale
Standard Deviation 0.70
|
1.6 units on a scale
Standard Deviation 0.77
|
1.6 units on a scale
Standard Deviation 0.78
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Week 16: Usual activities
|
2.0 units on a scale
Standard Deviation 0.88
|
2.1 units on a scale
Standard Deviation 0.91
|
2.0 units on a scale
Standard Deviation 0.86
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Week 16: Pain/Discomfort
|
2.3 units on a scale
Standard Deviation 0.92
|
2.4 units on a scale
Standard Deviation 0.87
|
2.3 units on a scale
Standard Deviation 0.81
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Week 16: Anxiety/Depression
|
1.3 units on a scale
Standard Deviation 0.64
|
1.4 units on a scale
Standard Deviation 0.66
|
1.3 units on a scale
Standard Deviation 0.62
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Baseline: Self-care
|
2.3 units on a scale
Standard Deviation 0.88
|
2.2 units on a scale
Standard Deviation 0.90
|
2.3 units on a scale
Standard Deviation 0.90
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Week 8: Self-care
|
1.6 units on a scale
Standard Deviation 0.79
|
1.6 units on a scale
Standard Deviation 0.78
|
1.5 units on a scale
Standard Deviation 0.76
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Week 8: Usual activities
|
2.1 units on a scale
Standard Deviation 0.83
|
2.2 units on a scale
Standard Deviation 0.85
|
2.1 units on a scale
Standard Deviation 0.84
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Week 8: Anxiety/Depression
|
1.4 units on a scale
Standard Deviation 0.65
|
1.4 units on a scale
Standard Deviation 0.67
|
1.3 units on a scale
Standard Deviation 0.56
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score
Week 16: Mobility
|
2.0 units on a scale
Standard Deviation 0.89
|
2.2 units on a scale
Standard Deviation 0.89
|
2.1 units on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8 and 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are \<=1. The Overall health utility score for a patient with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a patient reports greater levels of problems across the five dimensions.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value
Baseline
|
0.61 units on a scale
Standard Deviation 0.14
|
0.63 units on a scale
Standard Deviation 0.14
|
0.63 units on a scale
Standard Deviation 0.13
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value
Week 8
|
0.76 units on a scale
Standard Deviation 0.13
|
0.75 units on a scale
Standard Deviation 0.12
|
0.77 units on a scale
Standard Deviation 0.12
|
|
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value
Week 16
|
0.78 units on a scale
Standard Deviation 0.14
|
0.76 units on a scale
Standard Deviation 0.13
|
0.77 units on a scale
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 40Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Visits of services directly related to osteoarthritis evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline:Chiropractor
|
4.0 visits
Interval 1.0 to 120.0
|
2.0 visits
Interval 1.0 to 6.0
|
3.0 visits
Interval 1.0 to 10.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline:Nutritionist/Dietitian
|
1.0 visits
Interval 1.0 to 3.0
|
2.0 visits
Interval 1.0 to 4.0
|
2.0 visits
Interval 1.0 to 4.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline:Radiologist
|
1.0 visits
Interval 1.0 to 4.0
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline:Home healthcare services
|
2.0 visits
Interval 1.0 to 7.0
|
1.0 visits
Interval 1.0 to 1.0
|
2.0 visits
Interval 2.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline: Other Practitioner
|
1.0 visits
Interval 1.0 to 120.0
|
1.0 visits
Interval 1.0 to 90.0
|
1.0 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24:Primary Care Physician
|
1.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 100.0
|
1.0 visits
Interval 1.0 to 7.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24: Neurologist
|
—
|
—
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24: Rheumatologist
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24: Physician Assistant Or Nurse Practitioner
|
2.0 visits
Interval 2.0 to 2.0
|
1.0 visits
Interval 1.0 to 1.0
|
—
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24: Pain Specialist
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 5.0
|
1.0 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24: Orthopedist
|
2.0 visits
Interval 1.0 to 4.0
|
1.0 visits
Interval 1.0 to 101.0
|
1.0 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24: Physical Therapist
|
8.0 visits
Interval 1.0 to 20.0
|
2.5 visits
Interval 1.0 to 5.0
|
2.0 visits
Interval 1.0 to 11.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24: Chiropractor
|
2.5 visits
Interval 2.0 to 4.0
|
2.0 visits
Interval 1.0 to 16.0
|
1.0 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24: Alternative Medicine Or Therapy
|
1.0 visits
Interval 1.0 to 8.0
|
2.0 visits
Interval 1.0 to 6.0
|
1.0 visits
Interval 1.0 to 5.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24: Podiatrist
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24: Nutritionist/Dietitian
|
1.0 visits
Interval 1.0 to 1.0
|
2.5 visits
Interval 2.0 to 3.0
|
1.5 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24: Radiologist
|
1.0 visits
Interval 1.0 to 1.0
|
1.5 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 24: Other Practitioner
|
1.0 visits
Interval 1.0 to 6.0
|
1.0 visits
Interval 1.0 to 110.0
|
2.0 visits
Interval 1.0 to 190.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Primary Care Physician
|
1.0 visits
Interval 1.0 to 101.0
|
1.0 visits
Interval 1.0 to 11.0
|
1.0 visits
Interval 1.0 to 12.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Neurologist
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Rheumatologist
|
2.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Physician Assistant Or Nurse Practitioner
|
1.0 visits
Interval 1.0 to 111.0
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Pain Specialist
|
2.0 visits
Interval 1.0 to 5.0
|
1.5 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 111.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Orthopedist
|
1.0 visits
Interval 1.0 to 101.0
|
1.5 visits
Interval 1.0 to 190.0
|
1.0 visits
Interval 1.0 to 3.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Chiropractor
|
5.0 visits
Interval 1.0 to 16.0
|
1.0 visits
Interval 1.0 to 4.0
|
3.0 visits
Interval 1.0 to 4.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Alternative Medicine Or Therapy
|
2.5 visits
Interval 1.0 to 111.0
|
3.0 visits
Interval 1.0 to 6.0
|
1.5 visits
Interval 1.0 to 9.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Podiatrist
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Nutritionist/Dietitian
|
1.5 visits
Interval 1.0 to 2.0
|
—
|
3.5 visits
Interval 1.0 to 6.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Radiologist
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 3.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Home Healthcare Services
|
7.5 visits
Interval 3.0 to 11.0
|
1.0 visits
Interval 1.0 to 1.0
|
30.0 visits
Interval 30.0 to 30.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Other Practitioner
|
1.0 visits
Interval 1.0 to 111.0
|
2.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline:Primary Care Physician
|
1.0 visits
Interval 1.0 to 101.0
|
1.0 visits
Interval 1.0 to 190.0
|
1.0 visits
Interval 1.0 to 10.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline: Neurologist
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
2.0 visits
Interval 1.0 to 3.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline: Rheumatologist
|
1.5 visits
Interval 1.0 to 4.0
|
1.5 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline:Physician assistant or nurse practitioner
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 10.0
|
1.0 visits
Interval 1.0 to 6.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline:Pain specialist
|
1.0 visits
Interval 1.0 to 21.0
|
2.0 visits
Interval 1.0 to 10.0
|
3.0 visits
Interval 1.0 to 190.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline: Orthopedist
|
1.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 90.0
|
1.0 visits
Interval 1.0 to 5.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline: Physical therapist
|
3.0 visits
Interval 1.0 to 60.0
|
3.0 visits
Interval 1.0 to 24.0
|
2.0 visits
Interval 1.0 to 14.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline:Alternative medicine or therapy
|
2.0 visits
Interval 1.0 to 8.0
|
2.0 visits
Interval 1.0 to 90.0
|
2.0 visits
Interval 1.0 to 10.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Baseline:Podiatrist
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Week 40: Physical Therapist
|
4.0 visits
Interval 4.0 to 4.0
|
8.0 visits
Interval 1.0 to 12.0
|
6.0 visits
Interval 1.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 40Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of participants who visited the emergency room due to osteoarthritis (OA).
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis
Baseline
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis
Week 24
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis
Week 40
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 40Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of visits to the emergency room due to OA.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis
Week 24
|
2.5 visits
Interval 1.0 to 4.0
|
—
|
—
|
|
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis
Baseline
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
2.0 visits
Interval 1.0 to 3.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis
Week 40
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 40Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of participants who were hospitalized due to OA.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis
Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis
Week 24
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis
Week 40
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 40Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of nights stayed in the hospital due to OA.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis
Week 24
|
2.0 nights
Interval 1.0 to 3.0
|
3.0 nights
Interval 2.0 to 4.0
|
—
|
|
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis
Week 40
|
1.5 nights
Interval 1.0 to 2.0
|
3.5 nights
Interval 3.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 40Population: The intent to treat (ITT) population included all randomized participants who received at least one dose of subcutaneous (SC) study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Walking Aid Use · Sometimes
|
15 Participants
|
18 Participants
|
23 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Wheelchair Use · Rarely
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Wheelchair Use · Often
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Wheelchair Use · Always
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Device/Utensil to Dress Bathe Eat · Sometimes
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Device/Utensil to Dress Bathe Eat · Always
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Other Aids Or Devices:Never · Never
|
208 Participants
|
217 Participants
|
211 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Other Aids Or Devices:Never · Rarely
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Other Aids Or Devices:Never · Sometimes
|
14 Participants
|
4 Participants
|
7 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Other Aids Or Devices:Never · Often
|
6 Participants
|
5 Participants
|
5 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Other Aids Or Devices:Never · Always
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Wheelchair Use:Never · Sometimes
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Wheelchair Use:Never · Often
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Device/Utensil-Dress Bathe Eat · Always
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Other Aids Or Devices:Never · Sometimes
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Other Aids Or Devices:Never · Often
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Other Aids Or Devices:Never · Always
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40 :Walking Aid Use:Never · Rarely
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40 :Walking Aid Use:Never · Sometimes
|
7 Participants
|
13 Participants
|
5 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40 :Walking Aid Use:Never · Often
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40 :Walking Aid Use:Never · Always
|
7 Participants
|
4 Participants
|
7 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40 :Wheelchair Use:Never · Never
|
189 Participants
|
183 Participants
|
194 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40 :Wheelchair Use:Never · Sometimes
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40 :Wheelchair Use:Never · Often
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40 :Wheelchair Use:Never · Always
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40:Device/Utensil to Dress Bathe Eat · Never
|
188 Participants
|
183 Participants
|
191 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40:Device/Utensil to Dress Bathe Eat · Rarely
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40:Device/Utensil to Dress Bathe Eat · Sometimes
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40:Device/Utensil to Dress Bathe Eat · Often
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40:Device/Utensil to Dress Bathe Eat · Always
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40:Other Aids Or Devices:Never · Rarely
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40:Other Aids Or Devices:Never · Often
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40:Other Aids Or Devices:Never · Always
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Walking Aid Use · Rarely
|
10 Participants
|
2 Participants
|
5 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Walking Aid Use · Never
|
189 Participants
|
196 Participants
|
187 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Walking Aid Use · Often
|
13 Participants
|
11 Participants
|
10 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Walking Aid Use · Always
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Wheelchair Use · Never
|
230 Participants
|
229 Participants
|
230 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Wheelchair Use · Sometimes
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Device/Utensil to Dress Bathe Eat · Never
|
225 Participants
|
228 Participants
|
221 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Device/Utensil to Dress Bathe Eat · Rarely
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Device/Utensil to Dress Bathe Eat · Often
|
2 Participants
|
0 Participants
|
7 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24 :Walking Aid Use:Never · Never
|
175 Participants
|
168 Participants
|
185 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24 :Walking Aid Use:Never · Rarely
|
9 Participants
|
6 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24 :Walking Aid Use:Never · Sometimes
|
10 Participants
|
11 Participants
|
6 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24 :Walking Aid Use:Never · Often
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24 :Walking Aid Use:Never · Always
|
7 Participants
|
7 Participants
|
5 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Wheelchair Use:Never · Never
|
204 Participants
|
195 Participants
|
200 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Wheelchair Use:Never · Rarely
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Wheelchair Use:Never · Always
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Device/Utensil-Dress Bathe Eat · Never
|
203 Participants
|
195 Participants
|
200 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Device/Utensil-Dress Bathe Eat · Rarely
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Device/Utensil-Dress Bathe Eat · Sometimes
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Device/Utensil-Dress Bathe Eat · Often
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Other Aids Or Devices:Never · Never
|
199 Participants
|
189 Participants
|
197 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 24:Other Aids Or Devices:Never · Rarely
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40 :Walking Aid Use:Never · Never
|
170 Participants
|
164 Participants
|
175 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40 :Wheelchair Use:Never · Rarely
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40:Other Aids Or Devices:Never · Never
|
187 Participants
|
180 Participants
|
187 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 40:Other Aids Or Devices:Never · Sometimes
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 40Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 24 and Week 40. Domain evaluated was number of participants who quit job due to OA.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis
Baseline
|
11 Participants
|
7 Participants
|
9 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis
Week 24
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis
Week 40
|
8 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 40Population: ITT population: all randomized participants who received at least one dose of SC study medication (either Tanezumab or placebo). One additional participant apart from the ones who had responded for quitting job responded to duration since quitting job. 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 24 and Week 40. Domain evaluated was duration since quitting job due to OA.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis
Baseline
|
4.3 years
Interval 0.2 to 18.8
|
4.3 years
Interval 1.6 to 12.0
|
2.2 years
Interval 0.1 to 14.0
|
|
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis
Week 24
|
1.3 years
Interval 0.1 to 3.1
|
0.9 years
Interval 0.6 to 1.3
|
5.0 years
Interval 5.0 to 5.0
|
|
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis
Week 40
|
2.5 years
Interval 0.1 to 13.8
|
1.1 years
Interval 0.2 to 4.3
|
3.3 years
Interval 0.2 to 13.1
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
Number of participants who withdrew from treatment due to lack of efficacy have been reported here.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Number of Participants Who Withdrew Due to Lack of Efficacy
|
4 Participants
|
13 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Overall number of participants analyzed' signifies participants who discontinued from the study due to lack of efficacy.
Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=4 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=13 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=6 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Time to Discontinuation Due to Lack of Efficacy
|
NA days
Interval 43.0 to
Due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy, median and upper limit could not be calculated.
|
NA days
Interval 6.0 to
Due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy, median and upper limit could not be calculated.
|
NA days
Interval 53.0 to
Due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy, median and upper limit could not be calculated.
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12 and 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
In case of inadequate pain relief, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 16. Number of participants with any use of rescue medication during the particular study week were summarized.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16
Week 8
|
117 Participants
|
117 Participants
|
110 Participants
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16
Week 12
|
88 Participants
|
103 Participants
|
93 Participants
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16
Week 16
|
96 Participants
|
100 Participants
|
101 Participants
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16
Week 2
|
138 Participants
|
160 Participants
|
137 Participants
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16
Week 4
|
110 Participants
|
143 Participants
|
119 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Overall number of participants analyzed' signifies participants who took rescue medication.
In case of inadequate pain relief, after Week 16, acetaminophen up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during the 4 weeks up to the particular study week were summarized.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=199 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=189 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=202 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Number of Participants Who Took Rescue Medication During Week 24
|
118 Participants
|
108 Participants
|
125 Participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
In case of inadequate pain relief during the treatment period, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16
Week 4
|
1.68 days
Standard Error 0.19
|
2.20 days
Standard Error 0.25
|
1.93 days
Standard Error 0.22
|
|
Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16
Week 16
|
1.39 days
Standard Error 0.19
|
1.48 days
Standard Error 0.22
|
1.57 days
Standard Error 0.21
|
|
Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16
Week 2
|
2.02 days
Standard Error 0.19
|
2.46 days
Standard Error 0.24
|
2.27 days
Standard Error 0.22
|
|
Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16
Week 8
|
1.53 days
Standard Error 0.18
|
1.77 days
Standard Error 0.21
|
1.68 days
Standard Error 0.20
|
|
Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16
Week 12
|
1.12 days
Standard Error 0.16
|
1.45 days
Standard Error 0.21
|
1.31 days
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Week 24Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, 'Overall number of participants analyzed' signifies participants who took rescue medication.
In case of inadequate pain relief, after Week 16, acetaminophen up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days per week the participants used the rescue medication during the 4 weeks up to the particular study week were summarized.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=199 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=189 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=202 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Number of Days of Rescue Medication Use at Week 24
|
1.8 days
Standard Deviation 2.18
|
1.3 days
Standard Deviation 1.75
|
2.0 days
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).
In case of inadequate pain relief , acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16
Week 4
|
2005.3 milligrams
Standard Error 484.54
|
3033.2 milligrams
Standard Error 774.34
|
2815.6 milligrams
Standard Error 703.90
|
|
Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16
Week 8
|
2104.2 milligrams
Standard Error 556.57
|
2608.6 milligrams
Standard Error 706.60
|
2385.9 milligrams
Standard Error 633.42
|
|
Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16
Week 12
|
1633.4 milligrams
Standard Error 506.13
|
2121.2 milligrams
Standard Error 698.93
|
1810.1 milligrams
Standard Error 567.14
|
|
Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16
Week 16
|
2166.0 milligrams
Standard Error 670.55
|
2303.7 milligrams
Standard Error 747.74
|
2846.9 milligrams
Standard Error 906.15
|
|
Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16
Week 2
|
2537.6 milligrams
Standard Error 530.44
|
3226.0 milligrams
Standard Error 698.10
|
3139.1 milligrams
Standard Error 655.37
|
SECONDARY outcome
Timeframe: Baseline up to Week 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
143 Participants
|
145 Participants
|
156 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
11 Participants
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously.
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
33 Participants
|
31 Participants
|
40 Participants
|
|
Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here "Overall number of participants analysed" signifies participants who were evaluable for this outcome measure.
Primary Abnormality criteria: hemoglobin; hematocrit; RBC count \[less than{\<}0.8\* lower limit of normal\[LLN\]; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*ULN; platelets \<0.5\*LLN,\>1.75\*upper limit of normal (ULN); white blood cell count\<0.6\*LLN, \>1.5\*ULN; Lymphocytes,Leukocytes,Neutrophils \<0.8\*LLN, \>1.2\*ULN; Basophils, Eosinophils, Monocytes \>1.2\*ULN; Prothrombin time/Intl. normalized ratio \>1.1\*ULN; total bilirubin\>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase \>3.0\*ULN; total protein; albumin\<0.8\*LLN, \>1.2\*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides \>1.3\*ULN; Urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; glucose \<0.6\*LLN, \>1.5\*ULN;Hemoglobin A1C \>1.3\*ULN; creatine kinase \>2.0\*ULN, specific gravity \<1.003, \>1.030; pH\<4.5, \>8; Urine Leukocytes \>=20.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=212 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=204 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=208 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline
|
11 Participants
|
20 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here "Overall number of participants analysed" signifies participants who were evaluable for this outcome measure.
Primary Abnormality criteria: hemoglobin; hematocrit; RBC count \< 0.8\*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*ULN; platelets \<0.5\*LLN,\>1.75\*upper limit of normal (ULN); white blood cell count\<0.6\*LLN, \>1.5\*ULN; Lymphocytes, Leukocytes, Neutrophils \<0.8\*LLN, \>1.2\*ULN; Basophils, Eosinophils, Monocytes \>1.2\*ULN; Prothrombin time/Intl. normalized ratio \>1.1\*ULN; total bilirubin\>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase \>3.0\*ULN; total protein; albumin\<0.8\*LLN, \>1.2\*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides \>1.3\*ULN; Urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; glucose \<0.6\*LLN, \>1.5\*ULN; Hemoglobin A1C \>1.3\*ULN; creatine kinase \>2.0\*ULN; Urine erythrocytes \>=20.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=166 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=161 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=158 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline
|
3 Participants
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
Measurement of BP included sitting systolic (SBP) and diastolic BP (DBP).
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
SBP:Change at Week 12
|
-1.5 millimeters of mercury (mmHg)
Standard Deviation 12.33
|
-0.4 millimeters of mercury (mmHg)
Standard Deviation 13.90
|
-3.8 millimeters of mercury (mmHg)
Standard Deviation 11.93
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
SBP:Change at Week 16
|
-0.8 millimeters of mercury (mmHg)
Standard Deviation 12.52
|
-0.4 millimeters of mercury (mmHg)
Standard Deviation 10.79
|
-1.8 millimeters of mercury (mmHg)
Standard Deviation 11.71
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
SBP:Change at Week 24
|
0.7 millimeters of mercury (mmHg)
Standard Deviation 11.89
|
0.8 millimeters of mercury (mmHg)
Standard Deviation 12.05
|
0.1 millimeters of mercury (mmHg)
Standard Deviation 13.04
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
DBP: Baseline
|
77.9 millimeters of mercury (mmHg)
Standard Deviation 8.79
|
77.7 millimeters of mercury (mmHg)
Standard Deviation 8.25
|
78.0 millimeters of mercury (mmHg)
Standard Deviation 8.47
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
DBP:Change at Week 2
|
-0.6 millimeters of mercury (mmHg)
Standard Deviation 7.56
|
0.2 millimeters of mercury (mmHg)
Standard Deviation 7.41
|
-0.7 millimeters of mercury (mmHg)
Standard Deviation 7.60
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
DBP:Change at Week 4
|
-1.3 millimeters of mercury (mmHg)
Standard Deviation 7.52
|
-0.7 millimeters of mercury (mmHg)
Standard Deviation 7.55
|
-1.6 millimeters of mercury (mmHg)
Standard Deviation 8.36
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
DBP:Change at Week 8
|
-0.1 millimeters of mercury (mmHg)
Standard Deviation 8.18
|
-0.4 millimeters of mercury (mmHg)
Standard Deviation 7.41
|
-0.8 millimeters of mercury (mmHg)
Standard Deviation 7.90
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
DBP:Change at Week 12
|
-1.2 millimeters of mercury (mmHg)
Standard Deviation 8.49
|
-0.3 millimeters of mercury (mmHg)
Standard Deviation 8.59
|
-2.5 millimeters of mercury (mmHg)
Standard Deviation 8.13
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
DBP:Change at Week 16
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 8.55
|
0.2 millimeters of mercury (mmHg)
Standard Deviation 6.97
|
-1.8 millimeters of mercury (mmHg)
Standard Deviation 7.97
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
DBP:Change at Week 40
|
-0.6 millimeters of mercury (mmHg)
Standard Deviation 8.64
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 8.33
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 9.64
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
SBP: Baseline
|
127.3 millimeters of mercury (mmHg)
Standard Deviation 12.85
|
126.6 millimeters of mercury (mmHg)
Standard Deviation 11.11
|
126.4 millimeters of mercury (mmHg)
Standard Deviation 12.20
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
SBP:Change at Week 2
|
-0.8 millimeters of mercury (mmHg)
Standard Deviation 11.12
|
-0.7 millimeters of mercury (mmHg)
Standard Deviation 10.77
|
-1.8 millimeters of mercury (mmHg)
Standard Deviation 11.20
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
SBP:Change at Week 4
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 11.89
|
-1.2 millimeters of mercury (mmHg)
Standard Deviation 10.98
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 11.38
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
SBP:Change at Week 8
|
-0.7 millimeters of mercury (mmHg)
Standard Deviation 12.06
|
-0.4 millimeters of mercury (mmHg)
Standard Deviation 12.12
|
-1.7 millimeters of mercury (mmHg)
Standard Deviation 12.08
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
SBP:Change at Week 40
|
-0.1 millimeters of mercury (mmHg)
Standard Deviation 11.30
|
0.4 millimeters of mercury (mmHg)
Standard Deviation 12.61
|
-0.9 millimeters of mercury (mmHg)
Standard Deviation 12.66
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
DBP:Change at Week 24
|
0.2 millimeters of mercury (mmHg)
Standard Deviation 9.07
|
0.5 millimeters of mercury (mmHg)
Standard Deviation 7.85
|
-0.5 millimeters of mercury (mmHg)
Standard Deviation 8.74
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24 and 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified time points.
Heart rate was measured at sitting position.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40
Baseline
|
72.5 beats per minute
Standard Deviation 9.76
|
70.9 beats per minute
Standard Deviation 8.96
|
71.4 beats per minute
Standard Deviation 10.05
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40
Change at Week 2
|
0.3 beats per minute
Standard Deviation 8.12
|
0.7 beats per minute
Standard Deviation 7.71
|
1.1 beats per minute
Standard Deviation 8.40
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40
Change at Week 4
|
0.8 beats per minute
Standard Deviation 8.60
|
0.9 beats per minute
Standard Deviation 7.76
|
0.5 beats per minute
Standard Deviation 7.56
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40
Change at Week 16
|
-0.6 beats per minute
Standard Deviation 8.32
|
-0.0 beats per minute
Standard Deviation 8.47
|
0.3 beats per minute
Standard Deviation 8.82
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40
Change at Week 8
|
-0.1 beats per minute
Standard Deviation 7.91
|
0.2 beats per minute
Standard Deviation 8.65
|
-0.3 beats per minute
Standard Deviation 8.33
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40
Change at Week 12
|
0.0 beats per minute
Standard Deviation 8.81
|
0.6 beats per minute
Standard Deviation 8.24
|
1.1 beats per minute
Standard Deviation 8.07
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40
Change at Week 24
|
0.6 beats per minute
Standard Deviation 8.42
|
0.7 beats per minute
Standard Deviation 9.11
|
0.4 beats per minute
Standard Deviation 8.56
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40
Change at Week 40
|
0.2 beats per minute
Standard Deviation 8.49
|
0.7 beats per minute
Standard Deviation 8.72
|
0.5 beats per minute
Standard Deviation 10.11
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, QTcF, RR intervals) were collected.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
PR Interval: Baseline
|
162.9 millisecond
Standard Deviation 26.83
|
168.4 millisecond
Standard Deviation 26.20
|
163.2 millisecond
Standard Deviation 25.73
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
PR Interval:Change at Week 16
|
-0.3 millisecond
Standard Deviation 12.41
|
-1.7 millisecond
Standard Deviation 12.17
|
1.8 millisecond
Standard Deviation 12.08
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
PR Interval:Change at Week 40
|
-0.3 millisecond
Standard Deviation 12.65
|
-0.9 millisecond
Standard Deviation 13.63
|
-1.2 millisecond
Standard Deviation 13.37
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
QRS Interval:Change at Week 16
|
-1.1 millisecond
Standard Deviation 6.99
|
-0.3 millisecond
Standard Deviation 6.53
|
-0.4 millisecond
Standard Deviation 7.47
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
QRS Interval:Change at Week 40
|
-1.6 millisecond
Standard Deviation 7.76
|
-0.9 millisecond
Standard Deviation 7.36
|
-0.7 millisecond
Standard Deviation 7.71
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
QT Interval: Baseline
|
397.9 millisecond
Standard Deviation 26.26
|
401.3 millisecond
Standard Deviation 27.20
|
401.5 millisecond
Standard Deviation 28.82
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
QT Interval:Change at Week 16
|
-1.8 millisecond
Standard Deviation 21.20
|
-2.7 millisecond
Standard Deviation 21.24
|
-1.7 millisecond
Standard Deviation 22.08
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
QT Interval:Change at Week 40
|
-6.3 millisecond
Standard Deviation 22.68
|
-6.1 millisecond
Standard Deviation 21.14
|
-6.1 millisecond
Standard Deviation 20.67
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
QTCB Interval: Baseline
|
418.7 millisecond
Standard Deviation 21.55
|
417.4 millisecond
Standard Deviation 21.67
|
418.8 millisecond
Standard Deviation 20.45
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
QTCB Interval:Change at Week 16
|
0.4 millisecond
Standard Deviation 17.52
|
1.9 millisecond
Standard Deviation 16.59
|
1.2 millisecond
Standard Deviation 17.25
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
QTCB Interval:Change at Week 40
|
-2.0 millisecond
Standard Deviation 16.43
|
1.1 millisecond
Standard Deviation 15.97
|
0.3 millisecond
Standard Deviation 17.60
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
QTCF Interval: Baseline
|
411.4 millisecond
Standard Deviation 18.84
|
411.8 millisecond
Standard Deviation 18.93
|
412.7 millisecond
Standard Deviation 18.36
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
QTCF Interval:Change at Week 16
|
-0.4 millisecond
Standard Deviation 14.44
|
0.3 millisecond
Standard Deviation 13.85
|
0.2 millisecond
Standard Deviation 14.54
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
QTCF Interval:Change at Week 40
|
-3.5 millisecond
Standard Deviation 14.34
|
-1.4 millisecond
Standard Deviation 13.40
|
-1.9 millisecond
Standard Deviation 14.08
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
RR Interval: Baseline
|
911.0 millisecond
Standard Deviation 128.93
|
932.4 millisecond
Standard Deviation 137.58
|
927.3 millisecond
Standard Deviation 140.92
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
RR Interval:Change at Week 16
|
-10.1 millisecond
Standard Deviation 115.78
|
-20.4 millisecond
Standard Deviation 114.08
|
-13.1 millisecond
Standard Deviation 119.83
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
RR Interval:Change at Week 40
|
-22.1 millisecond
Standard Deviation 114.23
|
-31.6 millisecond
Standard Deviation 113.49
|
-28.5 millisecond
Standard Deviation 116.77
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
QRS Interval: Baseline
|
93.8 millisecond
Standard Deviation 12.56
|
94.8 millisecond
Standard Deviation 14.63
|
94.6 millisecond
Standard Deviation 11.69
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16 and 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40
Baseline
|
67.2 beats per minute
Standard Deviation 9.80
|
65.8 beats per minute
Standard Deviation 9.78
|
66.3 beats per minute
Standard Deviation 10.97
|
|
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40
Change at Week 16
|
0.8 beats per minute
Standard Deviation 8.74
|
1.3 beats per minute
Standard Deviation 8.68
|
0.9 beats per minute
Standard Deviation 8.81
|
|
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40
Change at Week 40
|
1.5 beats per minute
Standard Deviation 8.88
|
2.5 beats per minute
Standard Deviation 8.55
|
2.2 beats per minute
Standard Deviation 9.13
|
SECONDARY outcome
Timeframe: Baseline up to Week 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, 'Overall number of participants analyzed' signifies participants analyzed by adjudication committee.
Incidence of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive osteoarthritis (OA) (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=18 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=5 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=14 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Composite Joint Safety Endpoint
|
0.4 percentage of participants
Interval 0.0 to 2.4
|
0 percentage of participants
Interval 0.0 to 1.6
|
2.2 percentage of participants
Interval 0.7 to 5.0
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Rapidly Progressive OA
|
0.4 percentage of participants
Interval 0.0 to 2.4
|
0 percentage of participants
Interval 0.0 to 1.6
|
2.2 percentage of participants
Interval 0.7 to 5.0
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Rapidly Progressive OA type 1
|
0.4 percentage of participants
Interval 0.0 to 2.4
|
0 percentage of participants
Interval 0.0 to 1.6
|
1.3 percentage of participants
Interval 0.3 to 3.7
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Rapidly Progressive OA type 2
|
0.0 percentage of participants
Interval 0.0 to 1.6
|
0 percentage of participants
Interval 0.0 to 1.6
|
0.9 percentage of participants
Interval 0.1 to 3.1
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Primary Osteonecrosis
|
0 percentage of participants
Interval 0.0 to 1.6
|
0 percentage of participants
Interval 0.0 to 1.6
|
0 percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Pathological Fracture
|
0 percentage of participants
Interval 0.0 to 1.6
|
0 percentage of participants
Interval 0.0 to 1.6
|
0 percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Subchondral Insufficiency Fracture
|
0 percentage of participants
Interval 0.0 to 1.6
|
0 percentage of participants
Interval 0.0 to 1.6
|
0 percentage of participants
Interval 0.0 to 1.6
|
SECONDARY outcome
Timeframe: Baseline up to Week 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously.
Percentage of participants who underwent total knee, hip or shoulder joint replacement surgery.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Percentage of Participants With Total Joint Replacements
|
6.9 percentage of participants
Interval 4.0 to 10.9
|
1.7 percentage of participants
Interval 0.5 to 4.4
|
3.5 percentage of participants
Interval 1.5 to 6.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8,12,16, 24 and 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40
Change at Week 12
|
-0.28 units on a scale
Standard Deviation 2.24
|
-0.14 units on a scale
Standard Deviation 1.70
|
-0.31 units on a scale
Standard Deviation 2.37
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40
Change at Week 16
|
-0.35 units on a scale
Standard Deviation 2.72
|
-0.20 units on a scale
Standard Deviation 1.71
|
-0.24 units on a scale
Standard Deviation 2.28
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40
Change at Week 24
|
-0.29 units on a scale
Standard Deviation 2.60
|
-0.27 units on a scale
Standard Deviation 1.73
|
-0.16 units on a scale
Standard Deviation 1.83
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40
Change at Week 8
|
-0.16 units on a scale
Standard Deviation 1.73
|
-0.14 units on a scale
Standard Deviation 1.55
|
-0.22 units on a scale
Standard Deviation 2.06
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40
Change at Week 2
|
-0.31 units on a scale
Standard Deviation 1.59
|
-0.21 units on a scale
Standard Deviation 1.38
|
-0.14 units on a scale
Standard Deviation 1.64
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40
Change at Week 4
|
-0.32 units on a scale
Standard Deviation 1.88
|
-0.17 units on a scale
Standard Deviation 1.50
|
-0.15 units on a scale
Standard Deviation 2.37
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40
Baseline
|
1.80 units on a scale
Standard Deviation 4.50
|
1.09 units on a scale
Standard Deviation 2.60
|
2.01 units on a scale
Standard Deviation 4.75
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40
Change at Week 40
|
-0.52 units on a scale
Standard Deviation 2.55
|
-0.25 units on a scale
Standard Deviation 1.71
|
-0.25 units on a scale
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Baseline up to Week 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, 'Overall number of participants analyzed' signifies participants analyzed for this outcome measure.
Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP \<=150 mmHg (mean supine): Reduction in systolic BP\>=20 mmHg or reduction in diastolic BP\>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP \>150 mmHg (mean supine): Reduction in systolic BP\>=30 mmHg or reduction in diastolic BP\>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=228 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=227 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=230 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Number of Participants With Confirmed Orthostatic Hypotension
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40
Number of symptoms reported: Baseline
|
0.45 units on a scale
Standard Deviation 0.73
|
0.47 units on a scale
Standard Deviation 0.71
|
0.54 units on a scale
Standard Deviation 0.82
|
|
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40
Number of symptoms reported: Change at Week 24
|
0.38 units on a scale
Standard Deviation 1.26
|
0.42 units on a scale
Standard Deviation 1.33
|
0.30 units on a scale
Standard Deviation 1.25
|
|
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40
Number of symptoms reported: Change at Week 40
|
0.26 units on a scale
Standard Deviation 1.28
|
0.23 units on a scale
Standard Deviation 1.22
|
0.18 units on a scale
Standard Deviation 1.27
|
|
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40
Total Symptom Impact Score: Baseline
|
1.00 units on a scale
Standard Deviation 1.73
|
1.07 units on a scale
Standard Deviation 1.72
|
1.15 units on a scale
Standard Deviation 1.71
|
|
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40
Total Symptom Impact Score: Change at Week 40
|
0.96 units on a scale
Standard Deviation 3.46
|
0.83 units on a scale
Standard Deviation 3.43
|
0.89 units on a scale
Standard Deviation 3.79
|
|
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40
Total Symptom Impact Score: Change at Week 24
|
1.22 units on a scale
Standard Deviation 3.48
|
1.44 units on a scale
Standard Deviation 3.82
|
1.22 units on a scale
Standard Deviation 3.66
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8,16, 24 and 40Population: The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Participants listed as having anti-tanezumab antibodies had ADA titer level \>=3.32. Less than 3.32 was considered below the limit of quantitation.
Outcome measures
| Measure |
Tanezumab 2.5/5 mg
n=233 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
Placebo
n=232 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
|---|---|---|---|
|
Number of Participants With Anti-Tanezumab Antibodies
Baseline
|
23 Participants
|
25 Participants
|
25 Participants
|
|
Number of Participants With Anti-Tanezumab Antibodies
Week 8
|
36 Participants
|
22 Participants
|
29 Participants
|
|
Number of Participants With Anti-Tanezumab Antibodies
Week 16
|
43 Participants
|
16 Participants
|
35 Participants
|
|
Number of Participants With Anti-Tanezumab Antibodies
Week 24
|
40 Participants
|
15 Participants
|
30 Participants
|
|
Number of Participants With Anti-Tanezumab Antibodies
Week 40
|
33 Participants
|
18 Participants
|
29 Participants
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 143 other events
Deaths: 0 deaths
Tanezumab 2.5 mg
Serious events: 7 serious events
Other events: 155 other events
Deaths: 0 deaths
Tanezumab 2.5/5 mg
Serious events: 11 serious events
Other events: 141 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=232 participants at risk
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 participants at risk
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5/5 mg
n=233 participants at risk
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Cardiac disorders
Myocardial infarction
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Chest pain
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Pneumonia
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Abdominal hernia infection
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Cellulitis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
Other adverse events
| Measure |
Placebo
n=232 participants at risk
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5 mg
n=231 participants at risk
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
|
Tanezumab 2.5/5 mg
n=233 participants at risk
Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
|
|---|---|---|---|
|
General disorders
Feeling hot
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Injection site erythema
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Injection site pain
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Fatigue
|
1.3%
3/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Toothache
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Vomiting
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Asthenia
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Chest pain
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Cardiac disorders
Bradycardia
|
1.3%
3/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Cardiac disorders
Sinus bradycardia
|
1.7%
4/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Eye disorders
Cataract
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Eye disorders
Dry eye
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Eye disorders
Eye pruritus
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Vascular disorders
Hot flush
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Constipation
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Dental caries
|
1.3%
3/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Dental paraesthesia
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
4/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.2%
5/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
3.0%
7/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
4/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Injection site reaction
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Injection site swelling
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Malaise
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Oedema peripheral
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.2%
5/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
3.0%
7/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Pain
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Peripheral swelling
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Pyrexia
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Vascular disorders
Hypertension
|
2.2%
5/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Vascular disorders
Hypertensive crisis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Surgical and medical procedures
Dental prosthesis placement
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Surgical and medical procedures
Foot operation
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Surgical and medical procedures
Gingival graft
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Surgical and medical procedures
Nail operation
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Surgical and medical procedures
Toe operation
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Surgical and medical procedures
Tooth repair
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Bronchitis
|
2.2%
5/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
3.5%
8/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Cellulitis
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Diarrhoea infectious
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Diverticulitis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Ear infection
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Gastroenteritis
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
Blood cholesterol increased
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
Blood creatinine increased
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
Blood phosphorus decreased
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
Blood pressure increased
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
Blood urea increased
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
Blood urine present
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
Cardiac murmur
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
International normalised ratio decreased
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
Platelet count decreased
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
Weight increased
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
White blood cell count increased
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Metabolism and nutrition disorders
Gout
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
3/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.3%
3/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.7%
4/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Psychiatric disorders
Anxiety
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Psychiatric disorders
Depression
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Psychiatric disorders
Insomnia
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Psychiatric disorders
Sleep disorder due to general medical condition, insomnia type
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Decreased vibratory sense
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Dizziness
|
1.3%
3/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Dysarthria
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Headache
|
4.3%
10/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
3.9%
9/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
3.9%
9/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Hypoaesthesia
|
2.6%
6/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.2%
5/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.6%
6/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Nerve compression
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Paraesthesia
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
3.5%
8/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Restless legs syndrome
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Seizure
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Sinus headache
|
1.3%
3/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Influenza
|
2.2%
5/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.2%
5/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Localised infection
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
16/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
8.7%
20/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
7.3%
17/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Pharyngitis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Postoperative wound infection
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Sinobronchitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Sinusitis
|
2.2%
5/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.6%
6/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Skin infection
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Tooth abscess
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
9/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
4.8%
11/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
4.3%
10/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Urinary tract infection
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Viral infection
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Wound infection bacterial
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Fall
|
3.9%
9/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
5.6%
13/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
4.3%
10/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.3%
3/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.2%
5/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Limb fracture
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.2%
5/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.2%
5/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.3%
3/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Repetitive strain injury
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.2%
40/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
14.7%
34/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
14.6%
34/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
9/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
5.6%
13/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
3.4%
8/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Joint noise
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.2%
5/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.1%
5/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.2%
5/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
3.9%
9/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.6%
6/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.3%
3/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.1%
5/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.7%
11/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
7.4%
17/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
3.4%
8/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
4/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.2%
5/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
2.2%
5/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
3/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
3.9%
9/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
3.9%
9/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Ear and labyrinth disorders
Deafness
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Acid peptic disease
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Dry mouth
|
1.3%
3/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.86%
2/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Hyperthermia
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
General disorders
Thirst
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Hepatobiliary disorders
Cholestasis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Psychiatric disorders
Confusional state
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Renal and urinary disorders
Incontinence
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract inflammation
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Surgical and medical procedures
Artificial crown procedure
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Surgical and medical procedures
Blepharoplasty
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Vascular disorders
Hypotension
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Vascular disorders
Lymphoedema
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Device related infection
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Kidney infection
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Otitis media
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Pneumonia
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Joint warmth
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Ligament pain
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Subchondral insufficiency fracture
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.87%
2/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Skin and subcutaneous tissue disorders
Skin neoplasm excision
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Infections and infestations
Viral rhinitis
|
0.43%
1/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Rapidly progressive osteoarthritis
|
0.00%
0/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
1.7%
4/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.43%
1/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.86%
2/232 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/231 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
0.00%
0/233 • Baseline up to Week 40 (end of study)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER