Trial Outcomes & Findings for Extension Study Of Tanezumab In Osteoarthritis (NCT NCT00809783)
NCT ID: NCT00809783
Last Updated: 2021-05-10
Results Overview
AE:any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE:an AE resulting in any of 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 are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
2147 participants
Primary outcome timeframe
A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)
Results posted on
2021-05-10
Participant Flow
Participants randomized and treated with study medication in parent studies A4091011 (NCT00733902), A4091014 (NCT00744471), A4091015 (NCT00830063) and A4091018 (NCT00863304) who had completed the treatment period or discontinued due to lack of efficacy were eligible to enroll in this study.
533 participants who received placebo and 294 participants who received naproxen in parent studies were randomized to receive tanezumab 2.5, 5 or 10 milligram (mg) on Day 1. The remaining participants who received tanezumab in parent studies remained on the same dose they received in parent studies.
Participant milestones
| Measure |
Tanezumab 2.5 mg
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
525
|
832
|
790
|
|
Overall Study
Treated
|
522
|
832
|
788
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
525
|
832
|
790
|
Reasons for withdrawal
| Measure |
Tanezumab 2.5 mg
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
34
|
52
|
71
|
|
Overall Study
Lack of Efficacy
|
39
|
52
|
63
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
47
|
72
|
64
|
|
Overall Study
Protocol Violation
|
2
|
6
|
5
|
|
Overall Study
Randomized, but not treated
|
3
|
0
|
2
|
|
Overall Study
Study Terminated by Sponsor
|
378
|
626
|
565
|
|
Overall Study
Other
|
21
|
21
|
16
|
Baseline Characteristics
Extension Study Of Tanezumab In Osteoarthritis
Baseline characteristics by cohort
| Measure |
Tanezumab 2.5 mg
n=522 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=832 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=788 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Total
n=2142 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 to 44 years
|
29 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Age, Customized
45 to 64 years
|
298 Participants
n=5 Participants
|
466 Participants
n=7 Participants
|
455 Participants
n=5 Participants
|
1219 Participants
n=4 Participants
|
|
Age, Customized
Greater than or equal to 65 years
|
195 Participants
n=5 Participants
|
323 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
819 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
308 Participants
n=5 Participants
|
522 Participants
n=7 Participants
|
474 Participants
n=5 Participants
|
1304 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
214 Participants
n=5 Participants
|
310 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
838 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)Population: Intent to treat (ITT) analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).
AE:any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE:an AE resulting in any of 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 are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=522 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=832 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=788 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
AEs
|
363 Participants
|
573 Participants
|
547 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
SAEs
|
47 Participants
|
73 Participants
|
96 Participants
|
PRIMARY outcome
Timeframe: A4091016: Day 1 up to Week 80Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783). "Overall number of participants analyzed" signifies those participants who were evaluable for this measure.
Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(\<)0.8\*lower limit of normal(LLN),MCV,MCH,MCHC\<0.9\*LLN or \>1.1\*ULN,platelet:\<0.5\*LLN or \>1.75\*upper limit of normal(ULN),white blood cell(WBC):\<0.6\*LLN or \>1.5\*ULN,lymphocyte,neutrophil,total neutrophil:\<0.8\*LLN or\>1.2\*ULN,basophil,eosinophil,monocyte:\>1.2\*ULN;total,direct bilirubin\>1.5\*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:\> 3.0\*ULN,total protein,albumin:\<0.8\*LLN or \>1.2\*ULN;blood urea nitrogen,creatinine:\>1.3\*ULN,uric acid\>1.2\*ULN;cholesterol,triglycerides\>1.3\*ULN;sodium \<0.95\*LLN or \>1.05\*ULN,potassium,chloride,calcium,magnesium,bicarbonate:\<0.9\*LLN or \>1.1\*ULN,phosphate\<0.8\*LLN or\>1.2\*ULN;glucose \<0.6\*LLN or \>1.5\*ULN,glycosylated Hgb \>1.3\*ULN,creatine kinase\>2.0\*ULN;urine(specific gravity \<1.003or\>1.030,pH \<4.5or\>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals\>=1,RBC,WBC \>1.5\*ULN,epithelial cell\>=6,casts,hyaline cast\>1,bacteria\>20).
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=516 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=810 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=767 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Findings
|
439 Participants
|
679 Participants
|
624 Participants
|
PRIMARY outcome
Timeframe: A4091016: Baseline (Day 1) up to Week 80Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).
Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and VR interval. Number of participants with clinically significant abnormal ECG findings were judged by investigator and reported as adverse events were presented.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=522 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=832 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=788 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
|
14 Participants
|
33 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72Population: ITT population. Last observation carried forward (LOCF) method was used to impute missing values. "Overall number of participants analyzed" signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
NIS constitutes sum of 37 standard items of neuromuscular examination used to assess muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) scored on a scale: 0 (normal) to 4 (paralysis), with higher score=more weakness; components of reflexes and sensation (13 items) scored on a scale: 0= normal, 1= decreased or 2= absent. Total NIS score range 0 (no impairment) to 244 (maximum impairment), higher score = more impairment. Parent study baseline value calculated as average of pre-dose measurements of participants from study A4091011, A4091014, A4091015 and A4091018.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=522 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=832 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=785 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Parent Study Baseline
|
1.06 units on a scale
Standard Deviation 3.16
|
0.95 units on a scale
Standard Deviation 2.55
|
1.09 units on a scale
Standard Deviation 3.08
|
|
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4
|
-0.10 units on a scale
Standard Deviation 0.97
|
-0.04 units on a scale
Standard Deviation 1.15
|
-0.12 units on a scale
Standard Deviation 1.91
|
|
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8
|
-0.04 units on a scale
Standard Deviation 1.60
|
-0.02 units on a scale
Standard Deviation 1.43
|
-0.03 units on a scale
Standard Deviation 1.72
|
|
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16
|
-0.07 units on a scale
Standard Deviation 1.51
|
-0.03 units on a scale
Standard Deviation 1.79
|
-0.07 units on a scale
Standard Deviation 2.00
|
|
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24
|
-0.09 units on a scale
Standard Deviation 1.65
|
-0.04 units on a scale
Standard Deviation 1.74
|
-0.12 units on a scale
Standard Deviation 1.82
|
|
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32
|
-0.05 units on a scale
Standard Deviation 1.44
|
-0.02 units on a scale
Standard Deviation 1.66
|
-0.05 units on a scale
Standard Deviation 1.79
|
|
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40
|
-0.01 units on a scale
Standard Deviation 2.57
|
0.02 units on a scale
Standard Deviation 1.62
|
-0.11 units on a scale
Standard Deviation 1.93
|
|
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48
|
-0.04 units on a scale
Standard Deviation 2.47
|
-0.03 units on a scale
Standard Deviation 1.54
|
-0.11 units on a scale
Standard Deviation 1.89
|
|
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56
|
-0.02 units on a scale
Standard Deviation 2.61
|
-0.04 units on a scale
Standard Deviation 1.56
|
-0.11 units on a scale
Standard Deviation 1.89
|
|
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64
|
-0.04 units on a scale
Standard Deviation 2.58
|
-0.07 units on a scale
Standard Deviation 1.59
|
-0.12 units on a scale
Standard Deviation 1.89
|
|
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72
|
-0.04 units on a scale
Standard Deviation 2.57
|
-0.05 units on a scale
Standard Deviation 1.59
|
-0.11 units on a scale
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)Population: ITT population. "Overall number of participants analyzed" signifies those participants who were evaluable for this measure at any time point. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=492 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=775 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=733 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab
Week 72
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab
Day 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab
Week 16
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab
Week 24
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab
Week 40
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab
Week 56
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab
Week 80 or ET
|
2 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 80Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).
Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat and thyroid. Clinically significant changes were judged by investigator.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=522 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=832 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=788 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings
|
26 Participants
|
48 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: A4091016: Baseline (Day 1) up to Week 80Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).
Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs were judged by investigator and reported as adverse events were presented.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=522 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=832 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=788 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormality in Vital Signs
|
12 participants
|
13 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104Population: ITT population. LOCF method was used to impute missing values. "Overall number of participants analyzed" signifies those participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96 and 104 were not reported.
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=519 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=831 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=785 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 4
|
-4.47 units on a scale
Standard Deviation 2.31
|
-4.47 units on a scale
Standard Deviation 2.41
|
-4.52 units on a scale
Standard Deviation 2.48
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Parent Study Baseline
|
7.20 units on a scale
Standard Deviation 1.43
|
7.20 units on a scale
Standard Deviation 1.40
|
7.19 units on a scale
Standard Deviation 1.47
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 8
|
-4.04 units on a scale
Standard Deviation 2.52
|
-4.19 units on a scale
Standard Deviation 2.44
|
-4.45 units on a scale
Standard Deviation 2.53
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 16
|
-3.98 units on a scale
Standard Deviation 2.49
|
-4.08 units on a scale
Standard Deviation 2.47
|
-4.29 units on a scale
Standard Deviation 2.57
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 24
|
-3.88 units on a scale
Standard Deviation 2.52
|
-4.03 units on a scale
Standard Deviation 2.49
|
-4.17 units on a scale
Standard Deviation 2.62
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 32
|
-3.76 units on a scale
Standard Deviation 2.56
|
-3.95 units on a scale
Standard Deviation 2.56
|
-4.10 units on a scale
Standard Deviation 2.64
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 40
|
-3.73 units on a scale
Standard Deviation 2.59
|
-3.90 units on a scale
Standard Deviation 2.56
|
-4.07 units on a scale
Standard Deviation 2.66
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 48
|
-3.71 units on a scale
Standard Deviation 2.60
|
-3.87 units on a scale
Standard Deviation 2.55
|
-4.05 units on a scale
Standard Deviation 2.66
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 56
|
-3.72 units on a scale
Standard Deviation 2.59
|
-3.87 units on a scale
Standard Deviation 2.55
|
-4.03 units on a scale
Standard Deviation 2.67
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 64
|
-3.71 units on a scale
Standard Deviation 2.60
|
-3.86 units on a scale
Standard Deviation 2.56
|
-4.02 units on a scale
Standard Deviation 2.67
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 72
|
-3.71 units on a scale
Standard Deviation 2.60
|
-3.87 units on a scale
Standard Deviation 2.55
|
-4.02 units on a scale
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104Population: ITT population. LOCF method was used to impute missing values. "Overall number of participants analyzed" signifies those participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96 and 104 were not reported.
The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC physical function score is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=518 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=830 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=784 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 64
|
-3.16 units on a scale
Standard Deviation 2.65
|
-3.42 units on a scale
Standard Deviation 2.53
|
-3.59 units on a scale
Standard Deviation 2.65
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 72
|
-3.16 units on a scale
Standard Deviation 2.66
|
-3.42 units on a scale
Standard Deviation 2.53
|
-3.59 units on a scale
Standard Deviation 2.65
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Parent Study Baseline
|
6.75 units on a scale
Standard Deviation 1.62
|
6.81 units on a scale
Standard Deviation 1.57
|
6.81 units on a scale
Standard Deviation 1.61
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 4
|
-3.93 units on a scale
Standard Deviation 2.39
|
-4.05 units on a scale
Standard Deviation 2.38
|
-4.10 units on a scale
Standard Deviation 2.44
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 8
|
-3.47 units on a scale
Standard Deviation 2.59
|
-3.75 units on a scale
Standard Deviation 2.45
|
-4.05 units on a scale
Standard Deviation 2.49
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 16
|
-3.45 units on a scale
Standard Deviation 2.57
|
-3.65 units on a scale
Standard Deviation 2.46
|
-3.87 units on a scale
Standard Deviation 2.55
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 24
|
-3.34 units on a scale
Standard Deviation 2.60
|
-3.60 units on a scale
Standard Deviation 2.50
|
-3.74 units on a scale
Standard Deviation 2.60
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 32
|
-3.21 units on a scale
Standard Deviation 2.65
|
-3.51 units on a scale
Standard Deviation 2.54
|
-3.67 units on a scale
Standard Deviation 2.62
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 40
|
-3.18 units on a scale
Standard Deviation 2.66
|
-3.45 units on a scale
Standard Deviation 2.53
|
-3.64 units on a scale
Standard Deviation 2.65
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 48
|
-3.15 units on a scale
Standard Deviation 2.66
|
-3.44 units on a scale
Standard Deviation 2.52
|
-3.61 units on a scale
Standard Deviation 2.65
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 56
|
-3.16 units on a scale
Standard Deviation 2.65
|
-3.43 units on a scale
Standard Deviation 2.53
|
-3.59 units on a scale
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104Population: ITT population. LOCF method was used to impute missing values. '"Overall number of participants analyzed" = participants who were evaluable for this measure. "Number Analyzed" = participants who were evaluable for this measure at given time points for each group, respectively. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.
Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicate worse condition. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=519 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=829 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=785 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 8
|
-0.98 units on a scale
Standard Deviation 0.99
|
-1.08 units on a scale
Standard Deviation 0.96
|
-1.17 units on a scale
Standard Deviation 1.00
|
|
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 16
|
-0.94 units on a scale
Standard Deviation 0.95
|
-1.06 units on a scale
Standard Deviation 0.98
|
-1.10 units on a scale
Standard Deviation 0.99
|
|
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Parent Study Baseline
|
3.45 units on a scale
Standard Deviation 0.58
|
3.43 units on a scale
Standard Deviation 0.60
|
3.45 units on a scale
Standard Deviation 0.60
|
|
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 4
|
-1.18 units on a scale
Standard Deviation 0.93
|
-1.22 units on a scale
Standard Deviation 0.97
|
-1.22 units on a scale
Standard Deviation 0.99
|
|
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 24
|
-0.88 units on a scale
Standard Deviation 0.93
|
-1.01 units on a scale
Standard Deviation 0.99
|
-1.03 units on a scale
Standard Deviation 1.05
|
|
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 32
|
-0.88 units on a scale
Standard Deviation 0.95
|
-1.00 units on a scale
Standard Deviation 1.00
|
-1.01 units on a scale
Standard Deviation 1.06
|
|
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 40
|
-0.85 units on a scale
Standard Deviation 0.98
|
-0.94 units on a scale
Standard Deviation 1.00
|
-0.97 units on a scale
Standard Deviation 1.07
|
|
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 48
|
-0.83 units on a scale
Standard Deviation 0.98
|
-0.94 units on a scale
Standard Deviation 1.01
|
-0.97 units on a scale
Standard Deviation 1.08
|
|
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 56
|
-0.84 units on a scale
Standard Deviation 0.97
|
-0.94 units on a scale
Standard Deviation 1.01
|
-0.96 units on a scale
Standard Deviation 1.08
|
|
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 64
|
-0.83 units on a scale
Standard Deviation 0.97
|
-0.93 units on a scale
Standard Deviation 1.01
|
-0.96 units on a scale
Standard Deviation 1.09
|
|
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 72
|
-0.83 units on a scale
Standard Deviation 0.97
|
-0.93 units on a scale
Standard Deviation 1.01
|
-0.96 units on a scale
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783). LOCF method was used to impute missing values. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96 and 104 were not reported.
OMERACT-OARSI response:\>=50 percent(%) improvement from parent study baseline and absolute change from parent study baseline of \>=2 units at given week in WOMAC pain or physical function subscale or \>=20% improvement from parent study baseline and absolute change from parent study baseline of \>=1 unit at given week in at least 2 of following 3 items: 1)WOMAC pain subscale, 2)WOMAC physical function subscale, 3)PGA of osteoarthritis (score: 1-5, higher score=more affected).WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score:0-10, higher score=higher pain/difficulty).
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=522 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=832 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=788 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Week 32
|
75.1 percentage of participants
Interval 71.4 to 78.8
|
79.9 percentage of participants
Interval 77.2 to 82.6
|
80.2 percentage of participants
Interval 77.4 to 83.0
|
|
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Week 40
|
75.1 percentage of participants
Interval 71.4 to 78.8
|
79.3 percentage of participants
Interval 76.6 to 82.1
|
79.9 percentage of participants
Interval 77.2 to 82.7
|
|
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Week 48
|
74.5 percentage of participants
Interval 70.8 to 78.3
|
79.4 percentage of participants
Interval 76.7 to 82.2
|
79.6 percentage of participants
Interval 76.8 to 82.4
|
|
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Week 56
|
74.9 percentage of participants
Interval 71.2 to 78.6
|
79.3 percentage of participants
Interval 76.6 to 82.1
|
79.2 percentage of participants
Interval 76.4 to 82.0
|
|
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Week 64
|
74.5 percentage of participants
Interval 70.8 to 78.3
|
79.2 percentage of participants
Interval 76.4 to 82.0
|
79.2 percentage of participants
Interval 76.4 to 82.0
|
|
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Week 72
|
74.5 percentage of participants
Interval 70.8 to 78.3
|
79.2 percentage of participants
Interval 76.4 to 82.0
|
79.2 percentage of participants
Interval 76.4 to 82.0
|
|
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Week 4
|
86.8 percentage of participants
Interval 83.9 to 89.7
|
88.5 percentage of participants
Interval 86.3 to 90.6
|
86.0 percentage of participants
Interval 83.6 to 88.5
|
|
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Week 8
|
80.3 percentage of participants
Interval 76.9 to 83.7
|
83.5 percentage of participants
Interval 81.0 to 86.1
|
85.0 percentage of participants
Interval 82.5 to 87.5
|
|
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Week 16
|
80.1 percentage of participants
Interval 76.7 to 83.5
|
83.2 percentage of participants
Interval 80.6 to 85.7
|
82.9 percentage of participants
Interval 80.2 to 85.5
|
|
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Week 24
|
77.4 percentage of participants
Interval 73.8 to 81.0
|
82.0 percentage of participants
Interval 79.4 to 84.6
|
81.5 percentage of participants
Interval 78.8 to 84.2
|
SECONDARY outcome
Timeframe: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104Population: ITT population. LOCF method was used to impute missing values. "Overall number of participants analyzed" signifies those participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96 and 104 were not reported.
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=519 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=831 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=785 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 4: >=30% reduction
|
83.6 percentage of participants
|
82.6 percentage of participants
|
81.3 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 4: >=90% reduction
|
21.6 percentage of participants
|
23.1 percentage of participants
|
24.2 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 8: >=30% reduction
|
75.5 percentage of participants
|
78.6 percentage of participants
|
81.4 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 8: >=50% reduction
|
64.0 percentage of participants
|
63.9 percentage of participants
|
68.3 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 8: >=70% reduction
|
41.6 percentage of participants
|
43.2 percentage of participants
|
48.2 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 8: >=90% reduction
|
18.9 percentage of participants
|
20.7 percentage of participants
|
25.4 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 16: >=30% reduction
|
76.5 percentage of participants
|
76.9 percentage of participants
|
79.7 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 16: >=50% reduction
|
63.0 percentage of participants
|
61.4 percentage of participants
|
66.5 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 40: >=90% reduction
|
15.8 percentage of participants
|
19.4 percentage of participants
|
19.7 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 56: >=90% reduction
|
15.6 percentage of participants
|
19.0 percentage of participants
|
19.2 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 64: >=30% reduction
|
71.3 percentage of participants
|
73.8 percentage of participants
|
75.2 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 64: >=50% reduction
|
56.8 percentage of participants
|
58.2 percentage of participants
|
61.1 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 64: >=70% reduction
|
36.2 percentage of participants
|
39.8 percentage of participants
|
43.2 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 64: >=90% reduction
|
15.6 percentage of participants
|
19.0 percentage of participants
|
19.2 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 4: >=50% reduction
|
70.1 percentage of participants
|
68.7 percentage of participants
|
69.9 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 4: >=70% reduction
|
48.2 percentage of participants
|
50.9 percentage of participants
|
48.9 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 56: >=50% reduction
|
57.0 percentage of participants
|
58.1 percentage of participants
|
61.1 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 16: >=70% reduction
|
39.1 percentage of participants
|
42.0 percentage of participants
|
45.7 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 16: >=90% reduction
|
18.1 percentage of participants
|
18.8 percentage of participants
|
21.8 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 24: >=30% reduction
|
73.6 percentage of participants
|
77.4 percentage of participants
|
77.1 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 24: >=50% reduction
|
60.3 percentage of participants
|
61.6 percentage of participants
|
63.3 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 24: >=70% reduction
|
38.3 percentage of participants
|
40.3 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 24: >=90% reduction
|
16.8 percentage of participants
|
19.3 percentage of participants
|
21.5 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 32: >=30% reduction
|
72.6 percentage of participants
|
75.5 percentage of participants
|
75.9 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 32: >=50% reduction
|
57.4 percentage of participants
|
59.8 percentage of participants
|
62.7 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 32: >=70% reduction
|
36.8 percentage of participants
|
42.2 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 32: >=90% reduction
|
16.6 percentage of participants
|
19.1 percentage of participants
|
20.4 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 40: >=30% reduction
|
71.5 percentage of participants
|
74.4 percentage of participants
|
75.9 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 40: >=50% reduction
|
57.0 percentage of participants
|
58.1 percentage of participants
|
61.7 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 40: >=70% reduction
|
37.0 percentage of participants
|
41.2 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 48: >=30% reduction
|
71.1 percentage of participants
|
73.9 percentage of participants
|
75.4 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 48: >=50% reduction
|
56.6 percentage of participants
|
58.5 percentage of participants
|
61.4 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 48: >=70% reduction
|
35.8 percentage of participants
|
40.0 percentage of participants
|
43.4 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 48: >=90% reduction
|
15.4 percentage of participants
|
18.3 percentage of participants
|
19.5 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 56: >=30% reduction
|
71.5 percentage of participants
|
73.8 percentage of participants
|
75.2 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 56: >=70% reduction
|
36.0 percentage of participants
|
39.8 percentage of participants
|
43.2 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 72: >=30% reduction
|
71.3 percentage of participants
|
73.8 percentage of participants
|
75.2 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 72: >=50% reduction
|
56.8 percentage of participants
|
58.2 percentage of participants
|
61.0 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 72: >=70% reduction
|
36.2 percentage of participants
|
39.8 percentage of participants
|
43.1 percentage of participants
|
|
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Week 72: >=90% reduction
|
15.6 percentage of participants
|
19.0 percentage of participants
|
19.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 16, 24, 56, 104Population: ITT population. LOCF method was used to impute missing values. "Overall number of participants analyzed" signifies those participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 104 were not reported.
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=519 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=831 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=785 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 24: >=90% reduction
|
87 Participants
|
160 Participants
|
169 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 56: >=30% reduction
|
371 Participants
|
613 Participants
|
590 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 16: Greater than 0% reduction
|
478 Participants
|
782 Participants
|
733 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 16: >=10% reduction
|
462 Participants
|
750 Participants
|
708 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 16: >=20% reduction
|
431 Participants
|
701 Participants
|
665 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 16: >=30% reduction
|
397 Participants
|
639 Participants
|
626 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 16: >=40% reduction
|
358 Participants
|
573 Participants
|
577 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 16: >=50% reduction
|
327 Participants
|
510 Participants
|
522 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 16: >=60% reduction
|
267 Participants
|
432 Participants
|
453 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 16: >=70% reduction
|
203 Participants
|
349 Participants
|
359 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 16: >=80% reduction
|
149 Participants
|
264 Participants
|
271 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 16: >=90 reduction
|
94 Participants
|
156 Participants
|
171 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 16: 100% reduction
|
30 Participants
|
68 Participants
|
78 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 24: Greater than 0% reduction
|
477 Participants
|
782 Participants
|
734 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 24: >=10% reduction
|
457 Participants
|
750 Participants
|
703 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 24: >=20% reduction
|
419 Participants
|
692 Participants
|
655 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 24: >=30% reduction
|
382 Participants
|
643 Participants
|
605 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 24: >=40% reduction
|
352 Participants
|
567 Participants
|
552 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 24: >=50% reduction
|
313 Participants
|
512 Participants
|
497 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 24: >=60% reduction
|
264 Participants
|
425 Participants
|
432 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 24: >=70% reduction
|
199 Participants
|
335 Participants
|
357 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 24: >=80% reduction
|
141 Participants
|
255 Participants
|
271 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 24: 100% reduction
|
29 Participants
|
69 Participants
|
66 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 56: Greater than 0% reduction
|
470 Participants
|
773 Participants
|
726 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 56: >=10% reduction
|
449 Participants
|
735 Participants
|
689 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 56: >=20% reduction
|
409 Participants
|
677 Participants
|
640 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 56: >=40% reduction
|
334 Participants
|
545 Participants
|
538 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 56: >=50% reduction
|
296 Participants
|
483 Participants
|
480 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 56: >=60% reduction
|
249 Participants
|
404 Participants
|
414 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 56: >=70% reduction
|
187 Participants
|
331 Participants
|
339 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 56: >=80% reduction
|
128 Participants
|
250 Participants
|
255 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 56: >=90% reduction
|
81 Participants
|
158 Participants
|
151 Participants
|
|
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Week 56: 100% reduction
|
30 Participants
|
63 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104Population: ITT population. LOCF method was used to impute missing values. '"Overall number of participants analyzed" = participants who were evaluable for this measure. "Number Analyzed" = participants who were evaluable for this measure at given time points for each group, respectively. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.
Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicated worse pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=519 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=829 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=785 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
Week 48
|
24.7 percentage of participants
Interval 21.0 to 28.4
|
26.7 percentage of participants
Interval 23.6 to 29.7
|
30.3 percentage of participants
Interval 27.1 to 33.5
|
|
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
Week 4
|
37.6 percentage of participants
Interval 33.4 to 41.7
|
36.6 percentage of participants
Interval 33.3 to 39.9
|
37.3 percentage of participants
Interval 33.9 to 40.7
|
|
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
Week 8
|
28.9 percentage of participants
Interval 25.0 to 32.8
|
31.0 percentage of participants
Interval 27.9 to 34.1
|
34.9 percentage of participants
Interval 31.6 to 38.2
|
|
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
Week 16
|
29.9 percentage of participants
Interval 25.9 to 33.8
|
30.8 percentage of participants
Interval 27.6 to 33.9
|
31.7 percentage of participants
Interval 28.5 to 35.0
|
|
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
Week 24
|
25.8 percentage of participants
Interval 22.1 to 29.6
|
28.7 percentage of participants
Interval 25.6 to 31.8
|
32.4 percentage of participants
Interval 29.1 to 35.6
|
|
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
Week 32
|
25.8 percentage of participants
Interval 22.1 to 29.6
|
28.3 percentage of participants
Interval 25.3 to 31.4
|
31.0 percentage of participants
Interval 27.7 to 34.2
|
|
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
Week 40
|
25.4 percentage of participants
Interval 21.7 to 29.2
|
26.1 percentage of participants
Interval 23.1 to 29.0
|
29.9 percentage of participants
Interval 26.7 to 33.1
|
|
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
Week 56
|
24.7 percentage of participants
Interval 21.0 to 28.4
|
26.5 percentage of participants
Interval 23.5 to 29.5
|
30.2 percentage of participants
Interval 27.0 to 33.4
|
|
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
Week 64
|
24.7 percentage of participants
Interval 21.0 to 28.4
|
26.3 percentage of participants
Interval 23.3 to 29.3
|
30.1 percentage of participants
Interval 26.9 to 33.3
|
|
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
Week 72
|
24.7 percentage of participants
Interval 21.0 to 28.4
|
26.3 percentage of participants
Interval 23.3 to 29.3
|
30.1 percentage of participants
Interval 26.9 to 33.3
|
SECONDARY outcome
Timeframe: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104Population: ITT population. LOCF method was used to impute missing values. '"Overall number of participants analyzed" = participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.
WOMAC stiffness subscale: questionnaire used to assess amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. The WOMAC stiffness score is calculated as mean of scores from 2 individual questions scored on NRS of 0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score =0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Stiffness is defined as sensation of decreased ease in movement of knee/hip. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=519 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=831 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=785 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Parent Study Baseline
|
7.00 units on a scale
Standard Deviation 1.83
|
7.06 units on a scale
Standard Deviation 1.78
|
7.05 units on a scale
Standard Deviation 1.85
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 4
|
-4.14 units on a scale
Standard Deviation 2.66
|
-4.29 units on a scale
Standard Deviation 2.63
|
-4.36 units on a scale
Standard Deviation 2.73
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 8
|
-3.69 units on a scale
Standard Deviation 2.81
|
-4.00 units on a scale
Standard Deviation 2.71
|
-4.33 units on a scale
Standard Deviation 2.76
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 16
|
-3.56 units on a scale
Standard Deviation 2.83
|
-3.85 units on a scale
Standard Deviation 2.70
|
-4.10 units on a scale
Standard Deviation 2.84
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 24
|
-3.46 units on a scale
Standard Deviation 2.78
|
-3.81 units on a scale
Standard Deviation 2.71
|
-4.02 units on a scale
Standard Deviation 2.91
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 32
|
-3.35 units on a scale
Standard Deviation 2.83
|
-3.73 units on a scale
Standard Deviation 2.76
|
-3.91 units on a scale
Standard Deviation 2.95
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 40
|
-3.29 units on a scale
Standard Deviation 2.86
|
-3.65 units on a scale
Standard Deviation 2.79
|
-3.90 units on a scale
Standard Deviation 2.95
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 48
|
-3.25 units on a scale
Standard Deviation 2.87
|
-3.64 units on a scale
Standard Deviation 2.77
|
-3.87 units on a scale
Standard Deviation 2.96
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 56
|
-3.27 units on a scale
Standard Deviation 2.85
|
-3.63 units on a scale
Standard Deviation 2.77
|
-3.85 units on a scale
Standard Deviation 2.96
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 64
|
-3.26 units on a scale
Standard Deviation 2.86
|
-3.63 units on a scale
Standard Deviation 2.77
|
-3.85 units on a scale
Standard Deviation 2.96
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 72
|
-3.26 units on a scale
Standard Deviation 2.86
|
-3.63 units on a scale
Standard Deviation 2.77
|
-3.85 units on a scale
Standard Deviation 2.96
|
SECONDARY outcome
Timeframe: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104Population: ITT population. LOCF method was used to impute missing values. '"Overall number of participants analyzed" = participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (minimum difficulty) to 10 (maximum difficulty), where higher score indicates worse response. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=519 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=831 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=785 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 8
|
-3.74 units on a scale
Standard Deviation 2.49
|
-3.98 units on a scale
Standard Deviation 2.39
|
-4.28 units on a scale
Standard Deviation 2.45
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 16
|
-3.67 units on a scale
Standard Deviation 2.49
|
-3.86 units on a scale
Standard Deviation 2.40
|
-4.09 units on a scale
Standard Deviation 2.51
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 24
|
-3.57 units on a scale
Standard Deviation 2.50
|
-3.81 units on a scale
Standard Deviation 2.42
|
-3.98 units on a scale
Standard Deviation 2.57
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 32
|
-3.45 units on a scale
Standard Deviation 2.55
|
-3.73 units on a scale
Standard Deviation 2.48
|
-3.89 units on a scale
Standard Deviation 2.60
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 48
|
-3.38 units on a scale
Standard Deviation 2.58
|
-3.65 units on a scale
Standard Deviation 2.47
|
-3.85 units on a scale
Standard Deviation 2.62
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 56
|
-3.39 units on a scale
Standard Deviation 2.57
|
-3.64 units on a scale
Standard Deviation 2.47
|
-3.83 units on a scale
Standard Deviation 2.62
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 64
|
-3.39 units on a scale
Standard Deviation 2.58
|
-3.64 units on a scale
Standard Deviation 2.48
|
-3.82 units on a scale
Standard Deviation 2.63
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 72
|
-3.38 units on a scale
Standard Deviation 2.58
|
-3.64 units on a scale
Standard Deviation 2.48
|
-3.82 units on a scale
Standard Deviation 2.62
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Parent Study Baseline
|
6.98 units on a scale
Standard Deviation 1.44
|
7.02 units on a scale
Standard Deviation 1.43
|
7.01 units on a scale
Standard Deviation 1.46
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 4
|
-4.18 units on a scale
Standard Deviation 2.31
|
-4.27 units on a scale
Standard Deviation 2.33
|
-4.33 units on a scale
Standard Deviation 2.41
|
|
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 40
|
-3.41 units on a scale
Standard Deviation 2.57
|
-3.67 units on a scale
Standard Deviation 2.49
|
-3.87 units on a scale
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104Population: ITT population. LOCF method was used to impute missing values. '"Overall number of participants analyzed" = participants who were evaluable for this measure. "Number Analyzed" = participants who were evaluable for this measure at given time points for each group, respectively. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.
Participants answered: "How much pain have you had going up or down the stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=518 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=830 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=785 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Parent Study Baseline
|
8.14 units on a scale
Standard Deviation 1.48
|
8.11 units on a scale
Standard Deviation 1.48
|
8.16 units on a scale
Standard Deviation 1.51
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 4
|
-4.60 units on a scale
Standard Deviation 2.61
|
-4.54 units on a scale
Standard Deviation 2.74
|
-4.73 units on a scale
Standard Deviation 2.74
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 8
|
-4.15 units on a scale
Standard Deviation 2.83
|
-4.25 units on a scale
Standard Deviation 2.75
|
-4.69 units on a scale
Standard Deviation 2.83
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 16
|
-4.01 units on a scale
Standard Deviation 2.79
|
-4.05 units on a scale
Standard Deviation 2.85
|
-4.46 units on a scale
Standard Deviation 2.84
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 48
|
-3.72 units on a scale
Standard Deviation 2.88
|
-3.78 units on a scale
Standard Deviation 2.93
|
-4.19 units on a scale
Standard Deviation 2.95
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 56
|
-3.74 units on a scale
Standard Deviation 2.86
|
-3.80 units on a scale
Standard Deviation 2.94
|
-4.16 units on a scale
Standard Deviation 2.94
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 24
|
-3.85 units on a scale
Standard Deviation 2.86
|
-3.97 units on a scale
Standard Deviation 2.86
|
-4.33 units on a scale
Standard Deviation 2.91
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 32
|
-3.76 units on a scale
Standard Deviation 2.87
|
-3.87 units on a scale
Standard Deviation 2.91
|
-4.24 units on a scale
Standard Deviation 2.92
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 40
|
-3.70 units on a scale
Standard Deviation 2.92
|
-3.81 units on a scale
Standard Deviation 2.93
|
-4.21 units on a scale
Standard Deviation 2.94
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 64
|
-3.75 units on a scale
Standard Deviation 2.87
|
-3.79 units on a scale
Standard Deviation 2.94
|
-4.16 units on a scale
Standard Deviation 2.94
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 72
|
-3.74 units on a scale
Standard Deviation 2.87
|
-3.79 units on a scale
Standard Deviation 2.94
|
-4.15 units on a scale
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104Population: ITT population. LOCF method was used to impute missing values. '"Overall number of participants analyzed" = participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.
Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=519 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=831 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=785 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Parent Study Baseline
|
7.22 units on a scale
Standard Deviation 1.67
|
7.10 units on a scale
Standard Deviation 1.63
|
7.10 units on a scale
Standard Deviation 1.66
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 4
|
-4.51 units on a scale
Standard Deviation 2.54
|
-4.36 units on a scale
Standard Deviation 2.59
|
-4.38 units on a scale
Standard Deviation 2.67
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 8
|
-4.07 units on a scale
Standard Deviation 2.78
|
-4.03 units on a scale
Standard Deviation 2.65
|
-4.24 units on a scale
Standard Deviation 2.73
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 16
|
-3.96 units on a scale
Standard Deviation 2.74
|
-3.85 units on a scale
Standard Deviation 2.74
|
-4.12 units on a scale
Standard Deviation 2.84
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 24
|
-3.88 units on a scale
Standard Deviation 2.79
|
-3.83 units on a scale
Standard Deviation 2.72
|
-3.97 units on a scale
Standard Deviation 2.85
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 32
|
-3.74 units on a scale
Standard Deviation 2.78
|
-3.77 units on a scale
Standard Deviation 2.78
|
-3.88 units on a scale
Standard Deviation 2.87
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 40
|
-3.70 units on a scale
Standard Deviation 2.83
|
-3.68 units on a scale
Standard Deviation 2.80
|
-3.86 units on a scale
Standard Deviation 2.89
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 48
|
-3.72 units on a scale
Standard Deviation 2.82
|
-3.65 units on a scale
Standard Deviation 2.78
|
-3.83 units on a scale
Standard Deviation 2.90
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 56
|
-3.71 units on a scale
Standard Deviation 2.81
|
-3.66 units on a scale
Standard Deviation 2.78
|
-3.81 units on a scale
Standard Deviation 2.91
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 64
|
-3.72 units on a scale
Standard Deviation 2.82
|
-3.65 units on a scale
Standard Deviation 2.79
|
-3.80 units on a scale
Standard Deviation 2.91
|
|
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Change at Week 72
|
-3.71 units on a scale
Standard Deviation 2.82
|
-3.65 units on a scale
Standard Deviation 2.79
|
-3.80 units on a scale
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112Population: ITT population. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 73-80, 81-88, 89-96, 97-104 and 105-112 were not reported.
United States Food and Drug Administration (FDA) approved analgesics (over-the-counter or prescription) were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, non-steroidal anti inflammatory drugs (NSAIDs), capsaicin products, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed as per investigator's discretion.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=522 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=832 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=788 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Used Concomitant Analgesic Medication
Week 9-16
|
39.5 percentage of participants
|
44.4 percentage of participants
|
45.3 percentage of participants
|
|
Percentage of Participants Who Used Concomitant Analgesic Medication
Week 1-4
|
31.8 percentage of participants
|
28.7 percentage of participants
|
31.1 percentage of participants
|
|
Percentage of Participants Who Used Concomitant Analgesic Medication
Week 5-8
|
33.2 percentage of participants
|
35.4 percentage of participants
|
32.1 percentage of participants
|
|
Percentage of Participants Who Used Concomitant Analgesic Medication
Week 17-24
|
40.4 percentage of participants
|
43.4 percentage of participants
|
47.5 percentage of participants
|
|
Percentage of Participants Who Used Concomitant Analgesic Medication
Week 25-32
|
40.7 percentage of participants
|
34.1 percentage of participants
|
30.9 percentage of participants
|
|
Percentage of Participants Who Used Concomitant Analgesic Medication
Week 33-40
|
36.0 percentage of participants
|
26.4 percentage of participants
|
35.3 percentage of participants
|
|
Percentage of Participants Who Used Concomitant Analgesic Medication
Week 41-48
|
42.3 percentage of participants
|
19.1 percentage of participants
|
34.7 percentage of participants
|
|
Percentage of Participants Who Used Concomitant Analgesic Medication
Week 49-56
|
37.2 percentage of participants
|
34.0 percentage of participants
|
16.0 percentage of participants
|
|
Percentage of Participants Who Used Concomitant Analgesic Medication
Week 57-64
|
11.0 percentage of participants
|
28.1 percentage of participants
|
31.6 percentage of participants
|
|
Percentage of Participants Who Used Concomitant Analgesic Medication
Week 65-72
|
10.3 percentage of participants
|
4.7 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112Population: ITT population. 'Number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 73-80, 81-88, 89-96, 97-104 and 105-112 were not reported.
FDA approved analgesics (over-the-counter or prescription) were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, NSAIDs, capsaicin products, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed at the discretion of the investigator.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=522 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=832 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=788 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Days Per Week of Concomitant Analgesic Medication Usage
Week 1-4
|
1.8 days per week
Standard Deviation 2.98
|
1.6 days per week
Standard Deviation 2.83
|
1.7 days per week
Standard Deviation 2.85
|
|
Days Per Week of Concomitant Analgesic Medication Usage
Week 5-8
|
2.0 days per week
Standard Deviation 3.13
|
1.9 days per week
Standard Deviation 3.06
|
1.9 days per week
Standard Deviation 3.05
|
|
Days Per Week of Concomitant Analgesic Medication Usage
Week 9-16
|
2.1 days per week
Standard Deviation 3.09
|
2.0 days per week
Standard Deviation 3.07
|
1.9 days per week
Standard Deviation 3.00
|
|
Days Per Week of Concomitant Analgesic Medication Usage
Week 17-24
|
1.8 days per week
Standard Deviation 2.93
|
1.7 days per week
Standard Deviation 2.84
|
1.6 days per week
Standard Deviation 2.74
|
|
Days Per Week of Concomitant Analgesic Medication Usage
Week 25-32
|
1.7 days per week
Standard Deviation 2.89
|
1.4 days per week
Standard Deviation 2.64
|
1.3 days per week
Standard Deviation 2.58
|
|
Days Per Week of Concomitant Analgesic Medication Usage
Week 33-40
|
1.6 days per week
Standard Deviation 2.80
|
1.1 days per week
Standard Deviation 2.33
|
1.0 days per week
Standard Deviation 2.31
|
|
Days Per Week of Concomitant Analgesic Medication Usage
Week 41-48
|
1.3 days per week
Standard Deviation 2.59
|
0.8 days per week
Standard Deviation 2.08
|
0.7 days per week
Standard Deviation 1.94
|
|
Days Per Week of Concomitant Analgesic Medication Usage
Week 49-56
|
0.9 days per week
Standard Deviation 2.03
|
0.8 days per week
Standard Deviation 2.05
|
0.5 days per week
Standard Deviation 1.59
|
|
Days Per Week of Concomitant Analgesic Medication Usage
Week 57-64
|
0.5 days per week
Standard Deviation 1.66
|
0.4 days per week
Standard Deviation 1.39
|
0.2 days per week
Standard Deviation 0.67
|
|
Days Per Week of Concomitant Analgesic Medication Usage
Week 65-72
|
0.3 days per week
Standard Deviation 0.97
|
0.0 days per week
Standard Deviation 0.19
|
0.2 days per week
Standard Deviation 1.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: A4091016: Baseline (Day 1) up to Week 64Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).
Number of participants were reported based on the maximum number of intravenous doses of either tanezumab or placebo received.
Outcome measures
| Measure |
Tanezumab 2.5 mg
n=522 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=832 Participants
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=788 Participants
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Number of Participants Classified According to Number of Intravenous Doses of Study Medication
9 doses
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Classified According to Number of Intravenous Doses of Study Medication
1 dose
|
39 Participants
|
81 Participants
|
69 Participants
|
|
Number of Participants Classified According to Number of Intravenous Doses of Study Medication
2 doses
|
91 Participants
|
161 Participants
|
164 Participants
|
|
Number of Participants Classified According to Number of Intravenous Doses of Study Medication
3 doses
|
92 Participants
|
172 Participants
|
177 Participants
|
|
Number of Participants Classified According to Number of Intravenous Doses of Study Medication
4 doses
|
78 Participants
|
158 Participants
|
141 Participants
|
|
Number of Participants Classified According to Number of Intravenous Doses of Study Medication
5 doses
|
81 Participants
|
104 Participants
|
121 Participants
|
|
Number of Participants Classified According to Number of Intravenous Doses of Study Medication
6 doses
|
76 Participants
|
79 Participants
|
62 Participants
|
|
Number of Participants Classified According to Number of Intravenous Doses of Study Medication
7 doses
|
49 Participants
|
59 Participants
|
41 Participants
|
|
Number of Participants Classified According to Number of Intravenous Doses of Study Medication
8 doses
|
13 Participants
|
13 Participants
|
11 Participants
|
Adverse Events
Tanezumab 2.5 mg
Serious events: 47 serious events
Other events: 280 other events
Deaths: 0 deaths
Tanezumab 5 mg
Serious events: 73 serious events
Other events: 412 other events
Deaths: 0 deaths
Tanezumab 10 mg
Serious events: 96 serious events
Other events: 408 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tanezumab 2.5 mg
n=522 participants at risk
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=832 participants at risk
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=788 participants at risk
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.25%
2/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Atrial fibrillation
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.36%
3/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Bradycardia
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Cardiac arrest
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.24%
2/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Coronary artery disease
|
0.38%
2/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.36%
3/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Cardiac disorders
Ventricular failure
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
General disorders
Chest discomfort
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
General disorders
Chest pain
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.38%
3/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
General disorders
Oedema
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
General disorders
Pyrexia
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.25%
2/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Cellulitis
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.25%
2/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Haematoma infection
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Mastitis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.25%
2/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.25%
2/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Post procedural infection
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Sepsis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Urinary tract infection
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.25%
2/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.25%
2/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.25%
2/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.25%
2/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Investigations
Blood glucose increased
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Investigations
Blood urea increased
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Investigations
White blood cell count increased
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.77%
4/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.60%
5/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.76%
6/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.24%
2/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.38%
3/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.24%
2/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Chondrolysis
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.25%
2/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
9/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.6%
22/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
3.2%
25/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.1%
6/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.1%
9/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.6%
13/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.38%
2/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.24%
2/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.25%
2/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.38%
2/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal cancer
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.38%
3/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Nervous system disorders
Headache
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Nervous system disorders
Hydrocephalus
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Nervous system disorders
Sciatica
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Psychiatric disorders
Depression
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Psychiatric disorders
Suicidal ideation
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Renal and urinary disorders
Haematuria
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.12%
1/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.24%
2/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.38%
3/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.19%
1/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.36%
3/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.00%
0/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.13%
1/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
Other adverse events
| Measure |
Tanezumab 2.5 mg
n=522 participants at risk
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 5 mg
n=832 participants at risk
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
Tanezumab 10 mg
n=788 participants at risk
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
7/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.2%
18/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.0%
8/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
General disorders
Oedema peripheral
|
4.2%
22/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
6.2%
52/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
7.2%
57/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Bronchitis
|
1.5%
8/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.1%
9/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.0%
16/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
14/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.3%
19/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.3%
18/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Sinusitis
|
2.9%
15/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
3.1%
26/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.7%
21/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
36/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
5.0%
42/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
3.7%
29/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
29/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
6.9%
57/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
5.3%
42/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.3%
12/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.2%
10/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.2%
17/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
26/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.8%
23/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
5.1%
40/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.3%
12/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.4%
12/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.4%
19/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.9%
15/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.7%
14/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.6%
13/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.0%
73/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
13.9%
116/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
15.4%
121/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
20/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.6%
22/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
4.7%
37/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
1.5%
8/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.2%
18/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.3%
18/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.2%
27/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
4.4%
37/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
6.7%
53/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
11/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.8%
15/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.4%
11/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.2%
27/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
4.6%
38/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
4.1%
32/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.3%
33/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
6.0%
50/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
5.8%
46/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
31/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
4.4%
37/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
5.7%
45/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
1.1%
6/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.4%
12/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.2%
17/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.5%
8/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.4%
12/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.5%
20/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Nervous system disorders
Headache
|
4.4%
23/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
2.8%
23/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.6%
13/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Nervous system disorders
Hypoaesthesia
|
4.2%
22/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
5.0%
42/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
6.3%
50/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Nervous system disorders
Paraesthesia
|
3.8%
20/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
7.1%
59/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
7.5%
59/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
11/522
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
0.96%
8/832
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
1.1%
9/788
Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
|
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