Trial Outcomes & Findings for Tanezumab In Osteoarthritis Of The Knee (2) (NCT NCT00830063)
NCT ID: NCT00830063
Last Updated: 2021-05-13
Results Overview
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
832 participants
Primary outcome timeframe
Baseline (Day 1), Week 16
Results posted on
2021-05-13
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
208
|
208
|
208
|
208
|
|
Overall Study
Treated
|
208
|
206
|
208
|
206
|
|
Overall Study
COMPLETED
|
8
|
16
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
200
|
192
|
198
|
195
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
13
|
16
|
13
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
1
|
|
Overall Study
Preferred Time Entry in Extension Study
|
119
|
139
|
127
|
126
|
|
Overall Study
Lack of Efficacy
|
51
|
23
|
25
|
32
|
|
Overall Study
Other
|
5
|
5
|
8
|
6
|
|
Overall Study
Withdrawal by Subject
|
16
|
10
|
16
|
13
|
|
Overall Study
Protocol Violation
|
1
|
0
|
3
|
2
|
|
Overall Study
Randomized But Not Treated
|
0
|
2
|
0
|
2
|
Baseline Characteristics
Tanezumab In Osteoarthritis Of The Knee (2)
Baseline characteristics by cohort
| Measure |
Placebo
n=208 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=206 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=208 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=206 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
Total
n=828 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 10 • n=4 Participants
|
61.1 years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
499 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
329 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Week 16Population: Modified ITT (mITT): All participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here "Overall number of participants analyzed (N)" signifies the participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
Baseline
|
7.21 units on a scale
Standard Deviation 1.43
|
7.30 units on a scale
Standard Deviation 1.47
|
7.25 units on a scale
Standard Deviation 1.41
|
7.18 units on a scale
Standard Deviation 1.37
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16
|
-2.23 units on a scale
Standard Deviation 2.56
|
-3.55 units on a scale
Standard Deviation 2.84
|
-3.27 units on a scale
Standard Deviation 2.81
|
-2.82 units on a scale
Standard Deviation 2.54
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here 'N' signifies the participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=201 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
Baseline
|
6.85 units on a scale
Standard Deviation 1.56
|
6.86 units on a scale
Standard Deviation 1.71
|
6.86 units on a scale
Standard Deviation 1.50
|
6.86 units on a scale
Standard Deviation 1.57
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16
|
-1.88 units on a scale
Standard Deviation 2.29
|
-3.18 units on a scale
Standard Deviation 2.64
|
-2.91 units on a scale
Standard Deviation 2.59
|
-2.42 units on a scale
Standard Deviation 2.40
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies participants evaluable for this outcome measure.
Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=201 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)
Baseline
|
3.41 units on a scale
Standard Deviation 0.61
|
3.41 units on a scale
Standard Deviation 0.59
|
3.39 units on a scale
Standard Deviation 0.55
|
3.44 units on a scale
Standard Deviation 0.62
|
|
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16
|
-0.53 units on a scale
Standard Deviation 0.83
|
-0.87 units on a scale
Standard Deviation 1.02
|
-0.74 units on a scale
Standard Deviation 0.88
|
-0.70 units on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Change at Week 4
|
-2.36 units on a scale
Standard Deviation 2.31
|
-3.59 units on a scale
Standard Deviation 2.52
|
-3.99 units on a scale
Standard Deviation 2.64
|
-3.28 units on a scale
Standard Deviation 2.41
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Change at Week 8
|
-2.35 units on a scale
Standard Deviation 2.35
|
-3.63 units on a scale
Standard Deviation 2.61
|
-3.89 units on a scale
Standard Deviation 2.77
|
-3.13 units on a scale
Standard Deviation 2.57
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Change at Week 2
|
-2.34 units on a scale
Standard Deviation 2.26
|
-2.61 units on a scale
Standard Deviation 2.58
|
-2.95 units on a scale
Standard Deviation 2.53
|
-3.12 units on a scale
Standard Deviation 2.37
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Change at Week 12
|
-2.24 units on a scale
Standard Deviation 2.56
|
-3.89 units on a scale
Standard Deviation 2.83
|
-3.65 units on a scale
Standard Deviation 2.92
|
-2.98 units on a scale
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Baseline
|
7.21 units on a scale
Standard Deviation 1.43
|
7.30 units on a scale
Standard Deviation 1.47
|
7.25 units on a scale
Standard Deviation 1.41
|
7.18 units on a scale
Standard Deviation 1.37
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Change at Week 2
|
-2.34 units on a scale
Standard Deviation 2.26
|
-2.61 units on a scale
Standard Deviation 2.58
|
-2.95 units on a scale
Standard Deviation 2.53
|
-3.12 units on a scale
Standard Deviation 2.37
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Change at Week 4
|
-2.53 units on a scale
Standard Deviation 2.32
|
-3.58 units on a scale
Standard Deviation 2.56
|
-4.14 units on a scale
Standard Deviation 2.51
|
-3.32 units on a scale
Standard Deviation 2.39
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Change at Week 8
|
-2.62 units on a scale
Standard Deviation 2.35
|
-3.73 units on a scale
Standard Deviation 2.60
|
-4.24 units on a scale
Standard Deviation 2.53
|
-3.26 units on a scale
Standard Deviation 2.52
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Change at Week 12
|
-2.80 units on a scale
Standard Deviation 2.50
|
-4.07 units on a scale
Standard Deviation 2.72
|
-4.21 units on a scale
Standard Deviation 2.56
|
-3.34 units on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=201 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Change at Week 2
|
-1.92 units on a scale
Standard Deviation 2.09
|
-2.44 units on a scale
Standard Deviation 2.48
|
-2.80 units on a scale
Standard Deviation 2.35
|
-2.66 units on a scale
Standard Deviation 2.40
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Change at Week 4
|
-1.92 units on a scale
Standard Deviation 2.19
|
-3.07 units on a scale
Standard Deviation 2.47
|
-3.63 units on a scale
Standard Deviation 2.46
|
-2.90 units on a scale
Standard Deviation 2.38
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Change at Week 8
|
-1.96 units on a scale
Standard Deviation 2.14
|
-3.18 units on a scale
Standard Deviation 2.47
|
-3.50 units on a scale
Standard Deviation 2.57
|
-2.70 units on a scale
Standard Deviation 2.52
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Change at Week 12
|
-1.93 units on a scale
Standard Deviation 2.28
|
-3.46 units on a scale
Standard Deviation 2.70
|
-3.32 units on a scale
Standard Deviation 2.72
|
-2.66 units on a scale
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=201 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Baseline
|
6.85 units on a scale
Standard Deviation 1.56
|
6.86 units on a scale
Standard Deviation 1.71
|
6.86 units on a scale
Standard Deviation 1.50
|
6.86 units on a scale
Standard Deviation 1.57
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Change at Week 2
|
-1.92 units on a scale
Standard Deviation 2.09
|
-2.44 units on a scale
Standard Deviation 2.48
|
-2.80 units on a scale
Standard Deviation 2.35
|
-2.66 units on a scale
Standard Deviation 2.40
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Change at Week 4
|
-2.02 units on a scale
Standard Deviation 2.23
|
-3.07 units on a scale
Standard Deviation 2.54
|
-3.73 units on a scale
Standard Deviation 2.40
|
-2.93 units on a scale
Standard Deviation 2.37
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Change at Week 8
|
-2.13 units on a scale
Standard Deviation 2.22
|
-3.27 units on a scale
Standard Deviation 2.50
|
-3.77 units on a scale
Standard Deviation 2.45
|
-2.83 units on a scale
Standard Deviation 2.51
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Change at Week 12
|
-2.31 units on a scale
Standard Deviation 2.35
|
-3.61 units on a scale
Standard Deviation 2.67
|
-3.79 units on a scale
Standard Deviation 2.51
|
-2.95 units on a scale
Standard Deviation 2.52
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=201 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Change at Week 2
|
-0.53 units on a scale
Standard Deviation 0.78
|
-0.69 units on a scale
Standard Deviation 0.91
|
-0.68 units on a scale
Standard Deviation 0.90
|
-0.89 units on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Change at Week 4
|
-0.52 units on a scale
Standard Deviation 0.75
|
-1.02 units on a scale
Standard Deviation 0.98
|
-1.07 units on a scale
Standard Deviation 0.90
|
-0.89 units on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Change at Week 8
|
-0.52 units on a scale
Standard Deviation 0.81
|
-0.95 units on a scale
Standard Deviation 0.97
|
-0.96 units on a scale
Standard Deviation 0.95
|
-0.77 units on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Change at Week 12
|
-0.53 units on a scale
Standard Deviation 0.74
|
-0.98 units on a scale
Standard Deviation 1.00
|
-0.83 units on a scale
Standard Deviation 0.94
|
-0.73 units on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=201 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Baseline
|
3.41 units on a scale
Standard Deviation 0.61
|
3.41 units on a scale
Standard Deviation 0.59
|
3.39 units on a scale
Standard Deviation 0.55
|
3.44 units on a scale
Standard Deviation 0.62
|
|
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Change at Week 2
|
-0.53 units on a scale
Standard Deviation 0.78
|
-0.69 units on a scale
Standard Deviation 0.91
|
-0.68 units on a scale
Standard Deviation 0.90
|
-0.89 units on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Change at Week 4
|
-0.54 units on a scale
Standard Deviation 0.76
|
-1.01 units on a scale
Standard Deviation 1.01
|
-1.10 units on a scale
Standard Deviation 0.91
|
-0.91 units on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Change at Week 8
|
-0.56 units on a scale
Standard Deviation 0.83
|
-0.96 units on a scale
Standard Deviation 1.00
|
-1.05 units on a scale
Standard Deviation 0.95
|
-0.81 units on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Change at Week 12
|
-0.63 units on a scale
Standard Deviation 0.83
|
-1.01 units on a scale
Standard Deviation 1.04
|
-0.98 units on a scale
Standard Deviation 0.96
|
-0.82 units on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values.
A participant was considered as an OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (\>=) 50 percent and \>=2 units in WOMAC pain or physical function subscale; if improvement from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[minimum pain\] to 10 \[maximum pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 \[minimum affected\] to 5 \[maximum affected\], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=200 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=203 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)
Week 2
|
55.3 percentage of participants
|
61.9 percentage of participants
|
69.8 percentage of participants
|
67.0 percentage of participants
|
|
Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)
Week 4
|
53.3 percentage of participants
|
72.3 percentage of participants
|
76.2 percentage of participants
|
69.5 percentage of participants
|
|
Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)
Week 8
|
50.3 percentage of participants
|
72.8 percentage of participants
|
72.8 percentage of participants
|
67.0 percentage of participants
|
|
Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)
Week 12
|
48.7 percentage of participants
|
70.8 percentage of participants
|
66.8 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)
Week 16
|
50.3 percentage of participants
|
66.3 percentage of participants
|
63.9 percentage of participants
|
61.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values.
A participant was considered as an OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (\>=) 50 percent and \>=2 units in WOMAC pain or physical function subscale; if improvement from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[minimum pain\] to 10 \[maximum pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 \[minimum affected\] to 5 \[maximum affected\], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=200 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=203 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)
Week 2
|
55.3 percentage of participants
|
61.9 percentage of participants
|
69.8 percentage of participants
|
67.0 percentage of participants
|
|
Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)
Week 4
|
56.3 percentage of participants
|
73.8 percentage of participants
|
81.2 percentage of participants
|
70.5 percentage of participants
|
|
Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)
Week 8
|
56.3 percentage of participants
|
76.7 percentage of participants
|
81.7 percentage of participants
|
70.0 percentage of participants
|
|
Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)
Week 12
|
60.8 percentage of participants
|
77.2 percentage of participants
|
80.2 percentage of participants
|
69.0 percentage of participants
|
|
Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)
Week 16
|
61.8 percentage of participants
|
75.2 percentage of participants
|
80.2 percentage of participants
|
70.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale were reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
Week 2: >=30 percent reduction
|
46.7 percentage of participants
|
52.0 percentage of participants
|
58.4 percentage of participants
|
60.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
Week 2: >=50 percent reduction
|
29.6 percentage of participants
|
36.1 percentage of participants
|
41.6 percentage of participants
|
44.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
Week 4: >=30 percent reduction
|
47.2 percentage of participants
|
65.8 percentage of participants
|
72.8 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
Week 4: >=50 percent reduction
|
30.7 percentage of participants
|
52.0 percentage of participants
|
60.9 percentage of participants
|
48.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
Week 8: >=30 percent reduction
|
44.7 percentage of participants
|
68.3 percentage of participants
|
70.3 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
Week 8: >=50 percent reduction
|
31.7 percentage of participants
|
53.0 percentage of participants
|
60.4 percentage of participants
|
46.0 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
Week 12: >=30 percent reduction
|
44.2 percentage of participants
|
69.3 percentage of participants
|
65.8 percentage of participants
|
58.0 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
Week 12: >=50 percent reduction
|
32.7 percentage of participants
|
57.4 percentage of participants
|
57.9 percentage of participants
|
46.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
Week 16: >=30 percent reduction
|
42.7 percentage of participants
|
65.8 percentage of participants
|
59.4 percentage of participants
|
55.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
Week 16: >=50 percent reduction
|
31.2 percentage of participants
|
52.0 percentage of participants
|
52.0 percentage of participants
|
41.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale were reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
Week 16: >=30 percent reduction
|
54.3 percentage of participants
|
73.3 percentage of participants
|
73.3 percentage of participants
|
65.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
Week 16: >=50 percent reduction
|
37.7 percentage of participants
|
55.9 percentage of participants
|
61.9 percentage of participants
|
47.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
Week 2: >=30 percent reduction
|
46.7 percentage of participants
|
52.0 percentage of participants
|
58.4 percentage of participants
|
60.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
Week 2: >=50 percent reduction
|
29.6 percentage of participants
|
36.1 percentage of participants
|
41.6 percentage of participants
|
44.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
Week 4: >=30 percent reduction
|
51.3 percentage of participants
|
66.8 percentage of participants
|
76.7 percentage of participants
|
63.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
Week 4: >=50 percent reduction
|
32.7 percentage of participants
|
52.0 percentage of participants
|
63.4 percentage of participants
|
49.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
Week 8: >=30 percent reduction
|
51.8 percentage of participants
|
71.3 percentage of participants
|
78.2 percentage of participants
|
65.0 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
Week 8: >=50 percent reduction
|
35.2 percentage of participants
|
55.0 percentage of participants
|
65.3 percentage of participants
|
48.0 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
Week 12: >=30 percent reduction
|
56.8 percentage of participants
|
73.8 percentage of participants
|
77.2 percentage of participants
|
64.5 percentage of participants
|
|
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
Week 12: >=50 percent reduction
|
39.7 percentage of participants
|
59.9 percentage of participants
|
64.9 percentage of participants
|
51.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable at specific time points.
Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. Percentage of participants with at least 2 points improvement from baseline in PGA of osteoarthritis at specified weeks were reported.
Outcome measures
| Measure |
Placebo
n=200 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=203 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)
Week 2
|
11.0 percentage of participants
|
17.8 percentage of participants
|
16.8 percentage of participants
|
25.5 percentage of participants
|
|
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)
Week 4
|
9.0 percentage of participants
|
29.7 percentage of participants
|
30.0 percentage of participants
|
22.0 percentage of participants
|
|
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)
Week 8
|
9.5 percentage of participants
|
29.2 percentage of participants
|
28.6 percentage of participants
|
19.5 percentage of participants
|
|
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)
Week 12
|
12.5 percentage of participants
|
31.7 percentage of participants
|
24.8 percentage of participants
|
18.0 percentage of participants
|
|
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)
Week 16
|
13.5 percentage of participants
|
25.2 percentage of participants
|
19.8 percentage of participants
|
19.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable at specific time points.
Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. Percentage of participants with at least 2 points improvement from baseline in PGA of osteoarthritis at specified weeks were reported.
Outcome measures
| Measure |
Placebo
n=200 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=203 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)
Week 16
|
16.0 percentage of participants
|
27.7 percentage of participants
|
24.6 percentage of participants
|
22.5 percentage of participants
|
|
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)
Week 2
|
11.0 percentage of participants
|
17.8 percentage of participants
|
16.8 percentage of participants
|
25.5 percentage of participants
|
|
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)
Week 4
|
9.0 percentage of participants
|
29.7 percentage of participants
|
31.5 percentage of participants
|
22.5 percentage of participants
|
|
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)
Week 8
|
10.0 percentage of participants
|
29.7 percentage of participants
|
31.5 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)
Week 12
|
14.5 percentage of participants
|
33.7 percentage of participants
|
29.1 percentage of participants
|
20.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with cumulative reduction (greater than 0 percent \[%\]; \>= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
>=50 percent
|
31.2 percentage of participants
|
52.0 percentage of participants
|
52.0 percentage of participants
|
41.5 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
>=90 percent
|
8.0 percentage of participants
|
18.8 percentage of participants
|
17.8 percentage of participants
|
11.0 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
Greater than (>) 0 percent
|
57.3 percentage of participants
|
73.3 percentage of participants
|
69.3 percentage of participants
|
71.5 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
>=10 percent
|
54.3 percentage of participants
|
71.8 percentage of participants
|
66.3 percentage of participants
|
68.0 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
>=20 percent
|
50.8 percentage of participants
|
68.3 percentage of participants
|
64.4 percentage of participants
|
62.0 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
>=30 percent
|
42.7 percentage of participants
|
65.8 percentage of participants
|
59.4 percentage of participants
|
55.5 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
>=40 percent
|
36.7 percentage of participants
|
60.4 percentage of participants
|
56.4 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
>=60 percent
|
27.6 percentage of participants
|
49.5 percentage of participants
|
47.0 percentage of participants
|
35.5 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
>=70 percent
|
22.1 percentage of participants
|
39.1 percentage of participants
|
37.6 percentage of participants
|
26.0 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
>=80 percent
|
14.6 percentage of participants
|
29.2 percentage of participants
|
25.2 percentage of participants
|
18.0 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
100 percent
|
3.0 percentage of participants
|
8.4 percentage of participants
|
7.4 percentage of participants
|
4.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with cumulative reduction (greater than 0 percent \[%\]; \>= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
>=30 percent
|
54.3 percentage of participants
|
73.3 percentage of participants
|
73.3 percentage of participants
|
65.5 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
>=50 percent
|
37.7 percentage of participants
|
55.9 percentage of participants
|
61.9 percentage of participants
|
47.5 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
>0 percent
|
82.4 percentage of participants
|
87.6 percentage of participants
|
92.1 percentage of participants
|
91.5 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
>=10 percent
|
75.4 percentage of participants
|
83.2 percentage of participants
|
86.1 percentage of participants
|
83.0 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
>=20 percent
|
66.8 percentage of participants
|
77.7 percentage of participants
|
82.2 percentage of participants
|
73.0 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
>=40 percent
|
45.7 percentage of participants
|
66.3 percentage of participants
|
68.3 percentage of participants
|
57.0 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
>=60 percent
|
31.7 percentage of participants
|
53.0 percentage of participants
|
54.5 percentage of participants
|
41.0 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
>=70 percent
|
24.6 percentage of participants
|
41.6 percentage of participants
|
43.6 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
>=80 percent
|
15.6 percentage of participants
|
29.7 percentage of participants
|
28.7 percentage of participants
|
21.5 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
>=90 percent
|
9.0 percentage of participants
|
19.3 percentage of participants
|
19.8 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
100 percent
|
3.5 percentage of participants
|
8.9 percentage of participants
|
7.9 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
Participants assessed daily average pain score in the index knee using a scale ranging from 0 (no pain) to 10 (maximum pain), where higher scores indicate more pain. A weekly mean was calculated using the daily average index knee pain scores within each specified study week.
Outcome measures
| Measure |
Placebo
n=197 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=200 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=199 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=199 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16
|
-1.44 units on a scale
Standard Deviation 2.25
|
-2.54 units on a scale
Standard Deviation 2.77
|
-2.48 units on a scale
Standard Deviation 2.67
|
-2.21 units on a scale
Standard Deviation 2.53
|
|
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12
|
-1.53 units on a scale
Standard Deviation 2.32
|
-2.82 units on a scale
Standard Deviation 2.80
|
-2.79 units on a scale
Standard Deviation 2.63
|
-2.30 units on a scale
Standard Deviation 2.68
|
|
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline
|
6.46 units on a scale
Standard Deviation 1.83
|
6.51 units on a scale
Standard Deviation 1.98
|
6.58 units on a scale
Standard Deviation 1.70
|
6.70 units on a scale
Standard Deviation 1.99
|
|
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 2
|
-1.23 units on a scale
Standard Deviation 2.08
|
-1.80 units on a scale
Standard Deviation 2.45
|
-2.08 units on a scale
Standard Deviation 2.20
|
-2.39 units on a scale
Standard Deviation 2.28
|
|
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 4
|
-1.34 units on a scale
Standard Deviation 2.27
|
-2.46 units on a scale
Standard Deviation 2.52
|
-2.91 units on a scale
Standard Deviation 2.52
|
-2.33 units on a scale
Standard Deviation 2.33
|
|
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 8
|
-1.48 units on a scale
Standard Deviation 2.34
|
-2.52 units on a scale
Standard Deviation 2.72
|
-2.92 units on a scale
Standard Deviation 2.61
|
-2.42 units on a scale
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable at specific time points.
Participants assessed daily average pain score in the index knee using a scale ranging from 0 (no pain) to 10 (maximum pain), where higher scores indicate more pain. A weekly mean was calculated using the daily average index knee pain scores within each specified study week.
Outcome measures
| Measure |
Placebo
n=200 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=203 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12
|
-1.68 units on a scale
Standard Deviation 2.70
|
-3.03 units on a scale
Standard Deviation 2.73
|
-3.20 units on a scale
Standard Deviation 2.59
|
-2.67 units on a scale
Standard Deviation 2.67
|
|
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16
|
-1.67 units on a scale
Standard Deviation 2.68
|
-2.79 units on a scale
Standard Deviation 2.75
|
-2.96 units on a scale
Standard Deviation 2.66
|
-2.60 units on a scale
Standard Deviation 2.56
|
|
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Baseline
|
6.43 units on a scale
Standard Deviation 1.84
|
6.51 units on a scale
Standard Deviation 1.97
|
6.60 units on a scale
Standard Deviation 1.70
|
6.69 units on a scale
Standard Deviation 1.99
|
|
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 2
|
-1.25 units on a scale
Standard Deviation 2.10
|
-1.84 units on a scale
Standard Deviation 2.46
|
-2.09 units on a scale
Standard Deviation 2.20
|
-2.39 units on a scale
Standard Deviation 2.28
|
|
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 4
|
-1.33 units on a scale
Standard Deviation 2.38
|
-2.58 units on a scale
Standard Deviation 2.54
|
-2.96 units on a scale
Standard Deviation 2.54
|
-2.40 units on a scale
Standard Deviation 2.32
|
|
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 8
|
-1.45 units on a scale
Standard Deviation 2.51
|
-2.66 units on a scale
Standard Deviation 2.69
|
-3.13 units on a scale
Standard Deviation 2.58
|
-2.49 units on a scale
Standard Deviation 2.62
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in knee joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate greater stiffness. An overall possible WOMAC stiffness subscale score range is of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in moving the index knee.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 4
|
-1.76 units on a scale
Standard Deviation 2.44
|
-3.40 units on a scale
Standard Deviation 2.81
|
-3.84 units on a scale
Standard Deviation 2.73
|
-2.87 units on a scale
Standard Deviation 2.63
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12
|
-1.82 units on a scale
Standard Deviation 2.40
|
-3.73 units on a scale
Standard Deviation 2.88
|
-3.46 units on a scale
Standard Deviation 2.94
|
-2.62 units on a scale
Standard Deviation 2.70
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline
|
7.04 units on a scale
Standard Deviation 1.88
|
7.17 units on a scale
Standard Deviation 1.72
|
7.04 units on a scale
Standard Deviation 1.75
|
7.02 units on a scale
Standard Deviation 1.76
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 2
|
-1.69 units on a scale
Standard Deviation 2.36
|
-2.63 units on a scale
Standard Deviation 2.78
|
-2.98 units on a scale
Standard Deviation 2.63
|
-2.81 units on a scale
Standard Deviation 2.67
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 8
|
-1.77 units on a scale
Standard Deviation 2.26
|
-3.42 units on a scale
Standard Deviation 2.73
|
-3.68 units on a scale
Standard Deviation 2.81
|
-2.60 units on a scale
Standard Deviation 2.76
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16
|
-1.72 units on a scale
Standard Deviation 2.27
|
-3.33 units on a scale
Standard Deviation 2.84
|
-3.16 units on a scale
Standard Deviation 2.93
|
-2.31 units on a scale
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in knee joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate greater stiffness. An overall possible WOMAC stiffness subscale score range is of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in moving the index knee.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16
|
-2.07 units on a scale
Standard Deviation 2.43
|
-3.73 units on a scale
Standard Deviation 2.80
|
-3.91 units on a scale
Standard Deviation 2.68
|
-2.73 units on a scale
Standard Deviation 2.75
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Baseline
|
7.04 units on a scale
Standard Deviation 1.88
|
7.17 units on a scale
Standard Deviation 1.72
|
7.04 units on a scale
Standard Deviation 1.75
|
7.02 units on a scale
Standard Deviation 1.76
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 2
|
-1.69 units on a scale
Standard Deviation 2.36
|
-2.63 units on a scale
Standard Deviation 2.78
|
-2.98 units on a scale
Standard Deviation 2.63
|
-2.81 units on a scale
Standard Deviation 2.67
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 4
|
-1.81 units on a scale
Standard Deviation 2.53
|
-3.42 units on a scale
Standard Deviation 2.89
|
-3.95 units on a scale
Standard Deviation 2.63
|
-2.92 units on a scale
Standard Deviation 2.62
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 8
|
-1.95 units on a scale
Standard Deviation 2.34
|
-3.57 units on a scale
Standard Deviation 2.78
|
-4.00 units on a scale
Standard Deviation 2.68
|
-2.72 units on a scale
Standard Deviation 2.78
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12
|
-2.18 units on a scale
Standard Deviation 2.54
|
-3.99 units on a scale
Standard Deviation 2.86
|
-4.05 units on a scale
Standard Deviation 2.70
|
-2.91 units on a scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale assess amount of pain experienced (score: 0 \[minimum pain\] to 10 \[maximum pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = higher difficulty) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[minimum stiffness\] to 10 \[maximum stiffness\], higher score = higher stiffness). WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores, giving an overall possible WOMAC average score range of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse response.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline
|
7.03 units on a scale
Standard Deviation 1.48
|
7.11 units on a scale
Standard Deviation 1.46
|
7.05 units on a scale
Standard Deviation 1.38
|
7.02 units on a scale
Standard Deviation 1.37
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 2
|
-1.99 units on a scale
Standard Deviation 2.12
|
-2.56 units on a scale
Standard Deviation 2.47
|
-2.91 units on a scale
Standard Deviation 2.34
|
-2.86 units on a scale
Standard Deviation 2.35
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 4
|
-2.02 units on a scale
Standard Deviation 2.21
|
-3.35 units on a scale
Standard Deviation 2.49
|
-3.82 units on a scale
Standard Deviation 2.49
|
-3.02 units on a scale
Standard Deviation 2.33
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 8
|
-2.03 units on a scale
Standard Deviation 2.14
|
-3.41 units on a scale
Standard Deviation 2.49
|
-3.70 units on a scale
Standard Deviation 2.60
|
-2.81 units on a scale
Standard Deviation 2.49
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12
|
-2.00 units on a scale
Standard Deviation 2.35
|
-3.69 units on a scale
Standard Deviation 2.69
|
-3.48 units on a scale
Standard Deviation 2.77
|
-2.75 units on a scale
Standard Deviation 2.51
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16
|
-1.95 units on a scale
Standard Deviation 2.30
|
-3.35 units on a scale
Standard Deviation 2.66
|
-3.12 units on a scale
Standard Deviation 2.69
|
-2.52 units on a scale
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale assess amount of pain experienced (score: 0 \[minimum pain\] to 10 \[maximum pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = higher difficulty) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[minimum stiffness\] to 10 \[maximum stiffness\], higher score = higher stiffness). WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores, giving an overall possible WOMAC average score range of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse response.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Baseline
|
7.03 units on a scale
Standard Deviation 1.48
|
7.11 units on a scale
Standard Deviation 1.46
|
7.05 units on a scale
Standard Deviation 1.38
|
7.02 units on a scale
Standard Deviation 1.37
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 2
|
-1.99 units on a scale
Standard Deviation 2.12
|
-2.56 units on a scale
Standard Deviation 2.47
|
-2.91 units on a scale
Standard Deviation 2.34
|
-2.86 units on a scale
Standard Deviation 2.35
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 8
|
-2.23 units on a scale
Standard Deviation 2.18
|
-3.52 units on a scale
Standard Deviation 2.49
|
-4.00 units on a scale
Standard Deviation 2.41
|
-2.94 units on a scale
Standard Deviation 2.45
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 4
|
-2.13 units on a scale
Standard Deviation 2.23
|
-3.36 units on a scale
Standard Deviation 2.54
|
-3.94 units on a scale
Standard Deviation 2.38
|
-3.06 units on a scale
Standard Deviation 2.31
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12
|
-2.44 units on a scale
Standard Deviation 2.36
|
-3.89 units on a scale
Standard Deviation 2.61
|
-4.02 units on a scale
Standard Deviation 2.46
|
-3.06 units on a scale
Standard Deviation 2.47
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16
|
-2.37 units on a scale
Standard Deviation 2.33
|
-3.67 units on a scale
Standard Deviation 2.53
|
-3.82 units on a scale
Standard Deviation 2.38
|
-2.96 units on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when walking on a flat surface, where 0= no pain and 10= extreme pain. Higher score indicates more pain.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 2
|
-2.40 units on a scale
Standard Deviation 2.43
|
-2.52 units on a scale
Standard Deviation 2.72
|
-2.96 units on a scale
Standard Deviation 2.65
|
-3.05 units on a scale
Standard Deviation 2.60
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12
|
-2.28 units on a scale
Standard Deviation 2.67
|
-3.73 units on a scale
Standard Deviation 2.91
|
-3.50 units on a scale
Standard Deviation 2.98
|
-2.98 units on a scale
Standard Deviation 2.77
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline
|
7.22 units on a scale
Standard Deviation 1.65
|
7.16 units on a scale
Standard Deviation 1.79
|
7.08 units on a scale
Standard Deviation 1.70
|
7.04 units on a scale
Standard Deviation 1.71
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 4
|
-2.36 units on a scale
Standard Deviation 2.49
|
-3.49 units on a scale
Standard Deviation 2.67
|
-3.89 units on a scale
Standard Deviation 2.70
|
-3.30 units on a scale
Standard Deviation 2.48
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 8
|
-2.41 units on a scale
Standard Deviation 2.52
|
-3.52 units on a scale
Standard Deviation 2.78
|
-3.80 units on a scale
Standard Deviation 2.84
|
-3.05 units on a scale
Standard Deviation 2.72
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16
|
-2.26 units on a scale
Standard Deviation 2.70
|
-3.39 units on a scale
Standard Deviation 3.00
|
-3.10 units on a scale
Standard Deviation 2.83
|
-2.72 units on a scale
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when walking on a flat surface, where 0= no pain and 10= extreme pain. Higher score indicates more pain.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 4
|
-2.58 units on a scale
Standard Deviation 2.51
|
-3.53 units on a scale
Standard Deviation 2.65
|
-4.02 units on a scale
Standard Deviation 2.63
|
-3.35 units on a scale
Standard Deviation 2.44
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 8
|
-2.71 units on a scale
Standard Deviation 2.53
|
-3.65 units on a scale
Standard Deviation 2.74
|
-4.11 units on a scale
Standard Deviation 2.66
|
-3.23 units on a scale
Standard Deviation 2.65
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 2
|
-2.40 units on a scale
Standard Deviation 2.43
|
-2.52 units on a scale
Standard Deviation 2.72
|
-2.96 units on a scale
Standard Deviation 2.65
|
-3.05 units on a scale
Standard Deviation 2.60
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Baseline
|
7.22 units on a scale
Standard Deviation 1.65
|
7.16 units on a scale
Standard Deviation 1.79
|
7.08 units on a scale
Standard Deviation 1.70
|
7.04 units on a scale
Standard Deviation 1.71
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12
|
-2.87 units on a scale
Standard Deviation 2.64
|
-3.94 units on a scale
Standard Deviation 2.78
|
-4.01 units on a scale
Standard Deviation 2.72
|
-3.40 units on a scale
Standard Deviation 2.66
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16
|
-2.84 units on a scale
Standard Deviation 2.68
|
-3.71 units on a scale
Standard Deviation 2.83
|
-3.77 units on a scale
Standard Deviation 2.63
|
-3.28 units on a scale
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when going up or down stairs, where 0= no pain and 10= extreme pain. Higher score indicates more pain.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline
|
8.24 units on a scale
Standard Deviation 1.33
|
8.29 units on a scale
Standard Deviation 1.43
|
8.15 units on a scale
Standard Deviation 1.47
|
8.30 units on a scale
Standard Deviation 1.35
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 4
|
-2.18 units on a scale
Standard Deviation 2.49
|
-3.61 units on a scale
Standard Deviation 2.72
|
-4.18 units on a scale
Standard Deviation 2.90
|
-3.39 units on a scale
Standard Deviation 2.76
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12
|
-2.14 units on a scale
Standard Deviation 2.70
|
-4.01 units on a scale
Standard Deviation 3.00
|
-3.79 units on a scale
Standard Deviation 3.17
|
-3.06 units on a scale
Standard Deviation 2.96
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16
|
-2.21 units on a scale
Standard Deviation 2.73
|
-3.61 units on a scale
Standard Deviation 3.05
|
-3.38 units on a scale
Standard Deviation 3.09
|
-2.93 units on a scale
Standard Deviation 2.77
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 2
|
-2.19 units on a scale
Standard Deviation 2.50
|
-2.86 units on a scale
Standard Deviation 2.78
|
-3.10 units on a scale
Standard Deviation 2.68
|
-3.24 units on a scale
Standard Deviation 2.75
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 8
|
-2.15 units on a scale
Standard Deviation 2.55
|
-3.65 units on a scale
Standard Deviation 2.89
|
-3.98 units on a scale
Standard Deviation 3.00
|
-3.25 units on a scale
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when going up or down stairs, where 0= no pain and 10= extreme pain. Higher score indicates more pain.
Outcome measures
| Measure |
Placebo
n=199 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 2
|
-2.19 units on a scale
Standard Deviation 2.50
|
-2.86 units on a scale
Standard Deviation 2.78
|
-3.10 units on a scale
Standard Deviation 2.68
|
-3.24 units on a scale
Standard Deviation 2.75
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 4
|
-2.30 units on a scale
Standard Deviation 2.52
|
-3.65 units on a scale
Standard Deviation 2.70
|
-4.33 units on a scale
Standard Deviation 2.77
|
-3.44 units on a scale
Standard Deviation 2.73
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 8
|
-2.38 units on a scale
Standard Deviation 2.57
|
-3.81 units on a scale
Standard Deviation 2.82
|
-4.36 units on a scale
Standard Deviation 2.77
|
-3.40 units on a scale
Standard Deviation 2.84
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12
|
-2.61 units on a scale
Standard Deviation 2.68
|
-4.25 units on a scale
Standard Deviation 2.83
|
-4.35 units on a scale
Standard Deviation 2.84
|
-3.46 units on a scale
Standard Deviation 2.91
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16
|
-2.65 units on a scale
Standard Deviation 2.71
|
-3.99 units on a scale
Standard Deviation 2.84
|
-4.10 units on a scale
Standard Deviation 2.78
|
-3.48 units on a scale
Standard Deviation 2.69
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Baseline
|
8.24 units on a scale
Standard Deviation 1.33
|
8.29 units on a scale
Standard Deviation 1.43
|
8.15 units on a scale
Standard Deviation 1.47
|
8.30 units on a scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable for specific time points.
SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional and domain 8= mental health. Total score for each of the 8 domains are scaled from 0 (minimum level of functioning) to 100 (maximum level of functioning). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life.
Outcome measures
| Measure |
Placebo
n=200 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=203 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12:Domain 1
|
4.13 units on a scale
Standard Deviation 11.47
|
6.33 units on a scale
Standard Deviation 13.62
|
3.23 units on a scale
Standard Deviation 11.60
|
4.12 units on a scale
Standard Deviation 13.11
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16:Domain 1
|
3.42 units on a scale
Standard Deviation 11.57
|
4.03 units on a scale
Standard Deviation 14.02
|
3.31 units on a scale
Standard Deviation 11.32
|
3.62 units on a scale
Standard Deviation 12.40
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline: Domain 2
|
30.45 units on a scale
Standard Deviation 19.83
|
32.69 units on a scale
Standard Deviation 19.88
|
34.53 units on a scale
Standard Deviation 18.96
|
31.93 units on a scale
Standard Deviation 18.48
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12:Domain 2
|
10.15 units on a scale
Standard Deviation 18.50
|
18.45 units on a scale
Standard Deviation 22.97
|
17.47 units on a scale
Standard Deviation 23.51
|
12.69 units on a scale
Standard Deviation 19.68
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16:Domain 2
|
8.74 units on a scale
Standard Deviation 17.38
|
15.38 units on a scale
Standard Deviation 21.77
|
13.94 units on a scale
Standard Deviation 22.15
|
11.08 units on a scale
Standard Deviation 19.04
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline: Domain 3
|
43.62 units on a scale
Standard Deviation 25.48
|
44.21 units on a scale
Standard Deviation 26.10
|
46.50 units on a scale
Standard Deviation 23.89
|
45.44 units on a scale
Standard Deviation 25.54
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12:Domain 3
|
10.77 units on a scale
Standard Deviation 22.74
|
20.00 units on a scale
Standard Deviation 26.45
|
17.57 units on a scale
Standard Deviation 25.61
|
13.03 units on a scale
Standard Deviation 24.97
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16:Domain 3
|
9.64 units on a scale
Standard Deviation 21.87
|
17.33 units on a scale
Standard Deviation 27.01
|
15.10 units on a scale
Standard Deviation 23.84
|
11.69 units on a scale
Standard Deviation 22.79
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline: Domain 4
|
33.72 units on a scale
Standard Deviation 17.09
|
33.65 units on a scale
Standard Deviation 16.04
|
33.72 units on a scale
Standard Deviation 14.85
|
34.02 units on a scale
Standard Deviation 16.74
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline: Domain 1
|
66.03 units on a scale
Standard Deviation 19.88
|
67.19 units on a scale
Standard Deviation 17.71
|
67.64 units on a scale
Standard Deviation 19.71
|
65.16 units on a scale
Standard Deviation 19.77
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12:Domain 4
|
13.67 units on a scale
Standard Deviation 20.32
|
23.08 units on a scale
Standard Deviation 23.15
|
21.07 units on a scale
Standard Deviation 23.88
|
14.93 units on a scale
Standard Deviation 20.47
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16:Domain 4
|
11.23 units on a scale
Standard Deviation 18.48
|
18.99 units on a scale
Standard Deviation 22.90
|
16.76 units on a scale
Standard Deviation 21.85
|
13.19 units on a scale
Standard Deviation 21.19
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline: Domain 5
|
53.09 units on a scale
Standard Deviation 20.63
|
51.00 units on a scale
Standard Deviation 21.81
|
52.32 units on a scale
Standard Deviation 18.93
|
51.84 units on a scale
Standard Deviation 20.54
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12:Domain 5
|
4.39 units on a scale
Standard Deviation 12.54
|
10.29 units on a scale
Standard Deviation 18.21
|
6.96 units on a scale
Standard Deviation 16.19
|
7.19 units on a scale
Standard Deviation 14.89
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16:Domain 5
|
3.98 units on a scale
Standard Deviation 13.51
|
8.83 units on a scale
Standard Deviation 17.22
|
7.52 units on a scale
Standard Deviation 14.84
|
5.66 units on a scale
Standard Deviation 14.86
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline: Domain 6
|
69.28 units on a scale
Standard Deviation 27.86
|
68.53 units on a scale
Standard Deviation 26.43
|
69.86 units on a scale
Standard Deviation 25.08
|
67.94 units on a scale
Standard Deviation 25.48
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12:Domain 6
|
9.05 units on a scale
Standard Deviation 21.02
|
11.82 units on a scale
Standard Deviation 25.32
|
8.48 units on a scale
Standard Deviation 21.71
|
9.44 units on a scale
Standard Deviation 20.84
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16:Domain 6
|
6.97 units on a scale
Standard Deviation 20.78
|
11.63 units on a scale
Standard Deviation 24.76
|
7.43 units on a scale
Standard Deviation 18.80
|
8.00 units on a scale
Standard Deviation 22.90
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline: Domain 7
|
70.69 units on a scale
Standard Deviation 32.12
|
71.52 units on a scale
Standard Deviation 29.63
|
72.94 units on a scale
Standard Deviation 27.16
|
71.54 units on a scale
Standard Deviation 29.22
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12:Domain 7
|
6.03 units on a scale
Standard Deviation 19.98
|
9.00 units on a scale
Standard Deviation 26.96
|
6.06 units on a scale
Standard Deviation 18.70
|
4.88 units on a scale
Standard Deviation 24.57
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16:Domain 7
|
4.61 units on a scale
Standard Deviation 23.50
|
8.46 units on a scale
Standard Deviation 23.88
|
4.21 units on a scale
Standard Deviation 18.78
|
4.62 units on a scale
Standard Deviation 21.99
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline: Domain 8
|
76.06 units on a scale
Standard Deviation 18.01
|
75.80 units on a scale
Standard Deviation 17.76
|
74.48 units on a scale
Standard Deviation 17.95
|
74.91 units on a scale
Standard Deviation 17.79
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12:Domain 8
|
2.94 units on a scale
Standard Deviation 11.39
|
3.46 units on a scale
Standard Deviation 16.38
|
3.66 units on a scale
Standard Deviation 12.94
|
2.56 units on a scale
Standard Deviation 13.50
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16:Domain 8
|
1.66 units on a scale
Standard Deviation 13.81
|
3.21 units on a scale
Standard Deviation 15.31
|
2.97 units on a scale
Standard Deviation 12.37
|
2.31 units on a scale
Standard Deviation 13.32
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline: MCA
|
0.31 units on a scale
Standard Deviation 1.27
|
0.26 units on a scale
Standard Deviation 1.21
|
0.25 units on a scale
Standard Deviation 1.15
|
0.24 units on a scale
Standard Deviation 1.21
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12: MCA
|
0.15 units on a scale
Standard Deviation 0.70
|
0.16 units on a scale
Standard Deviation 1.03
|
0.07 units on a scale
Standard Deviation 0.76
|
0.11 units on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16: MCA
|
0.09 units on a scale
Standard Deviation 0.81
|
0.19 units on a scale
Standard Deviation 0.93
|
0.06 units on a scale
Standard Deviation 0.71
|
0.10 units on a scale
Standard Deviation 0.86
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline: PCA
|
-1.92 units on a scale
Standard Deviation 0.74
|
-1.85 units on a scale
Standard Deviation 0.76
|
-1.78 units on a scale
Standard Deviation 0.72
|
-1.86 units on a scale
Standard Deviation 0.78
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 12: PCA
|
0.47 units on a scale
Standard Deviation 0.74
|
0.88 units on a scale
Standard Deviation 0.90
|
0.77 units on a scale
Standard Deviation 0.93
|
0.59 units on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Change at Week 16: PCA
|
0.42 units on a scale
Standard Deviation 0.73
|
0.71 units on a scale
Standard Deviation 0.89
|
0.66 units on a scale
Standard Deviation 0.87
|
0.51 units on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable for specific time points.
SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional and domain 8= mental health. Total score for each of the 8 domains are scaled from 0 (minimum level of functioning) to 100 (maximum level of functioning). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life.
Outcome measures
| Measure |
Placebo
n=200 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=203 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Baseline: Domain 1
|
66.03 units on a scale
Standard Deviation 19.88
|
67.19 units on a scale
Standard Deviation 17.71
|
67.64 units on a scale
Standard Deviation 19.71
|
65.16 units on a scale
Standard Deviation 19.77
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12:Domain 1
|
4.13 units on a scale
Standard Deviation 11.47
|
6.33 units on a scale
Standard Deviation 13.62
|
3.23 units on a scale
Standard Deviation 11.60
|
4.12 units on a scale
Standard Deviation 13.11
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16:Domain 1
|
3.61 units on a scale
Standard Deviation 11.72
|
4.76 units on a scale
Standard Deviation 14.31
|
3.47 units on a scale
Standard Deviation 11.73
|
4.23 units on a scale
Standard Deviation 13.16
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Baseline: Domain 2
|
30.45 units on a scale
Standard Deviation 19.83
|
32.69 units on a scale
Standard Deviation 19.88
|
34.53 units on a scale
Standard Deviation 18.96
|
31.93 units on a scale
Standard Deviation 18.48
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12:Domain 2
|
10.15 units on a scale
Standard Deviation 18.50
|
18.45 units on a scale
Standard Deviation 22.97
|
17.47 units on a scale
Standard Deviation 23.51
|
12.69 units on a scale
Standard Deviation 19.68
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16:Domain 2
|
9.80 units on a scale
Standard Deviation 18.40
|
17.14 units on a scale
Standard Deviation 21.58
|
15.48 units on a scale
Standard Deviation 22.71
|
11.80 units on a scale
Standard Deviation 19.21
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Baseline: Domain 3
|
43.62 units on a scale
Standard Deviation 25.48
|
44.21 units on a scale
Standard Deviation 26.10
|
46.50 units on a scale
Standard Deviation 23.89
|
45.44 units on a scale
Standard Deviation 25.54
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12:Domain 3
|
10.77 units on a scale
Standard Deviation 22.74
|
20.00 units on a scale
Standard Deviation 26.45
|
17.57 units on a scale
Standard Deviation 25.61
|
13.03 units on a scale
Standard Deviation 24.97
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16:Domain 3
|
10.05 units on a scale
Standard Deviation 22.09
|
19.04 units on a scale
Standard Deviation 26.83
|
17.23 units on a scale
Standard Deviation 24.53
|
12.59 units on a scale
Standard Deviation 23.53
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Baseline: Domain 4
|
33.72 units on a scale
Standard Deviation 17.09
|
33.65 units on a scale
Standard Deviation 16.04
|
33.72 units on a scale
Standard Deviation 14.85
|
34.02 units on a scale
Standard Deviation 16.74
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12:Domain 4
|
13.67 units on a scale
Standard Deviation 20.32
|
23.08 units on a scale
Standard Deviation 23.15
|
21.07 units on a scale
Standard Deviation 23.88
|
14.93 units on a scale
Standard Deviation 20.47
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16:Domain 4
|
11.53 units on a scale
Standard Deviation 18.48
|
21.16 units on a scale
Standard Deviation 22.93
|
19.19 units on a scale
Standard Deviation 22.71
|
14.50 units on a scale
Standard Deviation 21.46
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Baseline: Domain 5
|
53.09 units on a scale
Standard Deviation 20.63
|
51.00 units on a scale
Standard Deviation 21.81
|
52.32 units on a scale
Standard Deviation 18.93
|
51.84 units on a scale
Standard Deviation 20.54
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12:Domain 5
|
4.39 units on a scale
Standard Deviation 12.54
|
10.29 units on a scale
Standard Deviation 18.21
|
6.96 units on a scale
Standard Deviation 16.19
|
7.19 units on a scale
Standard Deviation 14.89
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16:Domain 5
|
4.36 units on a scale
Standard Deviation 14.22
|
9.20 units on a scale
Standard Deviation 17.50
|
8.35 units on a scale
Standard Deviation 15.53
|
6.22 units on a scale
Standard Deviation 15.43
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Baseline: Domain 6
|
69.28 units on a scale
Standard Deviation 27.86
|
68.53 units on a scale
Standard Deviation 26.43
|
69.86 units on a scale
Standard Deviation 25.08
|
67.94 units on a scale
Standard Deviation 25.48
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12:Domain 6
|
9.05 units on a scale
Standard Deviation 21.02
|
11.82 units on a scale
Standard Deviation 25.32
|
8.48 units on a scale
Standard Deviation 21.71
|
9.44 units on a scale
Standard Deviation 20.84
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16:Domain 6
|
7.29 units on a scale
Standard Deviation 20.84
|
12.13 units on a scale
Standard Deviation 25.06
|
8.79 units on a scale
Standard Deviation 20.15
|
8.81 units on a scale
Standard Deviation 23.57
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Baseline: Domain 7
|
70.69 units on a scale
Standard Deviation 32.12
|
71.52 units on a scale
Standard Deviation 29.63
|
72.94 units on a scale
Standard Deviation 27.16
|
71.54 units on a scale
Standard Deviation 29.22
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12:Domain 7
|
6.03 units on a scale
Standard Deviation 19.98
|
9.00 units on a scale
Standard Deviation 26.96
|
6.06 units on a scale
Standard Deviation 18.70
|
4.88 units on a scale
Standard Deviation 24.57
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16:Domain 7
|
4.90 units on a scale
Standard Deviation 23.69
|
8.91 units on a scale
Standard Deviation 24.12
|
5.57 units on a scale
Standard Deviation 20.13
|
4.92 units on a scale
Standard Deviation 23.06
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Baseline: Domain 8
|
76.06 units on a scale
Standard Deviation 18.01
|
75.80 units on a scale
Standard Deviation 17.76
|
74.48 units on a scale
Standard Deviation 17.95
|
74.91 units on a scale
Standard Deviation 17.79
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12:Domain 8
|
2.94 units on a scale
Standard Deviation 11.39
|
3.46 units on a scale
Standard Deviation 16.38
|
3.66 units on a scale
Standard Deviation 12.94
|
2.56 units on a scale
Standard Deviation 13.50
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16:Domain 8
|
1.93 units on a scale
Standard Deviation 14.36
|
3.21 units on a scale
Standard Deviation 15.72
|
3.56 units on a scale
Standard Deviation 13.42
|
2.59 units on a scale
Standard Deviation 13.78
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Baseline: MCA
|
0.31 units on a scale
Standard Deviation 1.27
|
0.26 units on a scale
Standard Deviation 1.21
|
0.25 units on a scale
Standard Deviation 1.15
|
0.24 units on a scale
Standard Deviation 1.21
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12: MCA
|
0.15 units on a scale
Standard Deviation 0.70
|
0.16 units on a scale
Standard Deviation 1.03
|
0.07 units on a scale
Standard Deviation 0.76
|
0.11 units on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16: MCA
|
0.10 units on a scale
Standard Deviation 0.83
|
0.17 units on a scale
Standard Deviation 0.95
|
0.10 units on a scale
Standard Deviation 0.76
|
0.11 units on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Baseline: PCA
|
-1.92 units on a scale
Standard Deviation 0.74
|
-1.85 units on a scale
Standard Deviation 0.76
|
-1.78 units on a scale
Standard Deviation 0.72
|
-1.86 units on a scale
Standard Deviation 0.78
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 12: PCA
|
0.47 units on a scale
Standard Deviation 0.74
|
0.88 units on a scale
Standard Deviation 0.90
|
0.77 units on a scale
Standard Deviation 0.93
|
0.59 units on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Change at Week 16: PCA
|
0.45 units on a scale
Standard Deviation 0.74
|
0.80 units on a scale
Standard Deviation 0.88
|
0.73 units on a scale
Standard Deviation 0.88
|
0.56 units on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: ITT analysis set included all randomized participants who received at least 1 dose of the study drug.
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Placebo
n=208 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=206 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=208 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=206 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Time to Discontinuation Due to Lack of Efficacy
|
NA days
Median and full range cannot be estimated due to less number of participants with events.
|
NA days
Median and full range cannot be estimated due to less number of participants with events.
|
NA days
Median and full range cannot be estimated due to less number of participants with events.
|
NA days
Median and full range cannot be estimated due to less number of participants with events.
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values.
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the specified study week were summarized.
Outcome measures
| Measure |
Placebo
n=200 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=203 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Percentage of Participants Who Used Rescue Medication
Week 2
|
62.5 percentage of participants
|
47.3 percentage of participants
|
58.6 percentage of participants
|
49.7 percentage of participants
|
|
Percentage of Participants Who Used Rescue Medication
Week 4
|
59.5 percentage of participants
|
35.3 percentage of participants
|
38.9 percentage of participants
|
47.0 percentage of participants
|
|
Percentage of Participants Who Used Rescue Medication
Week 8
|
53.5 percentage of participants
|
35.8 percentage of participants
|
33.0 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Who Used Rescue Medication
Week 12
|
42.5 percentage of participants
|
29.4 percentage of participants
|
30.5 percentage of participants
|
32.0 percentage of participants
|
|
Percentage of Participants Who Used Rescue Medication
Week 16
|
40.5 percentage of participants
|
26.9 percentage of participants
|
25.1 percentage of participants
|
36.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable at specific time points.
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days participants used any of the rescue medication, during the specified week were summarized.
Outcome measures
| Measure |
Placebo
n=200 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=203 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Number of Days Participants Used Rescue Medication
Week 2
|
1 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
1 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
|
Number of Days Participants Used Rescue Medication
Week 4
|
1 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
|
Number of Days Participants Used Rescue Medication
Week 8
|
1 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
|
Number of Days Participants Used Rescue Medication
Week 12
|
0 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
|
Number of Days Participants Used Rescue Medication
Week 16
|
0 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16Population: mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable for specific time points.
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.
Outcome measures
| Measure |
Placebo
n=200 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=203 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=200 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Amount of Rescue Medication Taken
Week 12
|
2857.50 mg
Standard Deviation 5617.94
|
1238.81 mg
Standard Deviation 3024.10
|
1504.93 mg
Standard Deviation 4054.39
|
1800.00 mg
Standard Deviation 4034.40
|
|
Amount of Rescue Medication Taken
Week 2
|
3512.50 mg
Standard Deviation 5086.79
|
2644.28 mg
Standard Deviation 4867.40
|
2546.80 mg
Standard Deviation 3691.91
|
2025.13 mg
Standard Deviation 3468.75
|
|
Amount of Rescue Medication Taken
Week 4
|
3492.50 mg
Standard Deviation 5755.81
|
1773.63 mg
Standard Deviation 3849.64
|
1795.57 mg
Standard Deviation 4134.95
|
2210.00 mg
Standard Deviation 3887.99
|
|
Amount of Rescue Medication Taken
Week 8
|
3320.00 mg
Standard Deviation 5384.01
|
1684.08 mg
Standard Deviation 3506.56
|
1423.65 mg
Standard Deviation 3833.84
|
1987.50 mg
Standard Deviation 3967.02
|
|
Amount of Rescue Medication Taken
Week 16
|
2860.00 mg
Standard Deviation 5948.73
|
1427.86 mg
Standard Deviation 3733.77
|
1458.13 mg
Standard Deviation 4081.41
|
1872.50 mg
Standard Deviation 3967.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Baseline) up to Week 24Population: ITT analysis set included all randomized participants who received at least 1 dose of the study drug.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
Placebo
n=208 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=206 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=208 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=206 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
Adverse Events
|
99 Participants
|
107 Participants
|
122 Participants
|
104 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
Serious Adverse Events
|
8 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Baseline) up to Week 24Population: ITT analysis set included all randomized participants who received at least 1 dose of the study drug. Here, 'N' signifies number of participants evaluable for this outcome 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 |
Placebo
n=203 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=203 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=202 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=205 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
146 Participants
|
155 Participants
|
139 Participants
|
162 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Baseline) up to Week 24Population: ITT analysis set included all randomized participants who received at least 1 dose of the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for specific time points.
Criteria for potential clinical concern in ECG parameters are: Criterion 1= maximum QTcB interval (Bazett's correction) in range of 450 millisecond (msec) to less than 480 msec, Criterion 2= maximum QTcB interval in range of 480 msec to less than 500 msec, Criterion 3= maximum QTcB interval \>= 500 msec; Criterion 4= maximum QTcF interval (Fridericia's correction) in range of 450 msec to less than 480 msec, Criterion 5= maximum QTcF interval in range of 480 msec to less than 500 msec, Criterion 6= maximum QTcF interval \>= 500 msec, Criterion 7= maximum QTcB interval increase from baseline in range of 30 msec to less than 60 msec, Criterion 8= maximum QTcB interval increase \>=60 msec, Criterion 9= maximum QTcF interval increase from baseline in range of 30 msec to less than 60 msec, Criterion 10= maximum QTcF interval increase \>=60 msec.
Outcome measures
| Measure |
Placebo
n=208 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=206 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=208 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=206 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Criterion 1
|
35 Participants
|
39 Participants
|
38 Participants
|
45 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Criterion 2
|
8 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Criterion 3
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Criterion 4
|
13 Participants
|
16 Participants
|
13 Participants
|
9 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Criterion 5
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Criterion 6
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Criterion 7
|
29 Participants
|
25 Participants
|
28 Participants
|
27 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Criterion 8
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Criterion 9
|
13 Participants
|
18 Participants
|
21 Participants
|
21 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Criterion 10
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24Population: ITT analysis set included all randomized participants who received at least 1 dose of the study drug. LOCF method was used to impute missing values.
NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items from both the left and right side, where 24 items scored from 0 (normal function) to 4 (extreme abnormal function), higher score indicates higher abnormality and 13 items scored from 0 (normal function) to 2 (extreme abnormal function), higher score indicates higher abnormality. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicate increased impairment.
Outcome measures
| Measure |
Placebo
n=208 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=206 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=208 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=206 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24
Baseline
|
1.55 units on a scale
Standard Deviation 3.45
|
1.75 units on a scale
Standard Deviation 3.90
|
1.14 units on a scale
Standard Deviation 3.32
|
1.43 units on a scale
Standard Deviation 3.23
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24
Change at Week 2
|
-0.14 units on a scale
Standard Deviation 1.34
|
-0.37 units on a scale
Standard Deviation 2.49
|
0.14 units on a scale
Standard Deviation 2.28
|
-0.20 units on a scale
Standard Deviation 1.65
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24
Change at Week 4
|
-0.02 units on a scale
Standard Deviation 1.78
|
-0.50 units on a scale
Standard Deviation 2.70
|
-0.16 units on a scale
Standard Deviation 2.20
|
-0.25 units on a scale
Standard Deviation 1.71
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24
Change at Week 8
|
-0.12 units on a scale
Standard Deviation 2.14
|
-0.51 units on a scale
Standard Deviation 2.58
|
-0.00 units on a scale
Standard Deviation 2.71
|
-0.27 units on a scale
Standard Deviation 1.40
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24
Change at Week 12
|
-0.17 units on a scale
Standard Deviation 1.88
|
-0.42 units on a scale
Standard Deviation 2.53
|
-0.12 units on a scale
Standard Deviation 2.67
|
-0.25 units on a scale
Standard Deviation 1.58
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24
Change at Week 16
|
-0.11 units on a scale
Standard Deviation 1.70
|
-0.50 units on a scale
Standard Deviation 2.53
|
-0.21 units on a scale
Standard Deviation 2.69
|
-0.34 units on a scale
Standard Deviation 1.73
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24
Change at Week 24
|
-0.13 units on a scale
Standard Deviation 1.75
|
-0.51 units on a scale
Standard Deviation 2.50
|
-0.21 units on a scale
Standard Deviation 2.69
|
-0.34 units on a scale
Standard Deviation 1.70
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 8, 16, 24Population: Analysis set included all randomized participants who received at least 1 dose of the study drug. This outcome measure was planned not to be analyzed for reporting arms: placebo and naproxen + placebo.
Participants who developed anti-tanezumab antibodies after treatment were evaluated for the presence of anti-tanezumab neutralizing antibodies in their serum. Number of participants with positive ADA were summarized for reporting groups: tanezumab 5 mg + placebo and tanezumab 10 mg + placebo. Results with titer value \>= 4.32 nanogram per milliliter of anti-tanezumab neutralizing antibodies were counted as positive.
Outcome measures
| Measure |
Placebo
n=206 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=208 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) Level
Baseline
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) Level
Week 8
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) Level
Week 16
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) Level
Week 24
|
1 Participants
|
1 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Baseline) up to Week 24Population: ITT analysis set included all randomized participants who received at least 1 dose of the study drug.
Assessment of the clinical significance of vital sign changes was done per investigator judgment. Changes in vital signs determined to be clinically significant by the investigator were reported as adverse events.
Outcome measures
| Measure |
Placebo
n=208 Participants
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=206 Participants
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=208 Participants
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=206 Participants
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
Adverse Events
Placebo
Serious events: 8 serious events
Other events: 59 other events
Deaths: 0 deaths
Tanezumab 5 mg + Placebo
Serious events: 7 serious events
Other events: 70 other events
Deaths: 0 deaths
Tanezumab 10 mg + Placebo
Serious events: 6 serious events
Other events: 92 other events
Deaths: 0 deaths
Naproxen + Placebo
Serious events: 5 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=208 participants at risk
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=206 participants at risk
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=208 participants at risk
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=206 participants at risk
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Cardiac disorders
Cardiac arrest
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
General disorders
Chest pain
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Infections and infestations
Pneumonia
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.96%
2/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Renal and urinary disorders
Renal failure acute
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.96%
2/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Vascular disorders
Hypertension
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
Other adverse events
| Measure |
Placebo
n=208 participants at risk
Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
|
Tanezumab 5 mg + Placebo
n=206 participants at risk
Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Tanezumab 10 mg + Placebo
n=208 participants at risk
Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
|
Naproxen + Placebo
n=206 participants at risk
Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.9%
6/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
4/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.9%
4/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.9%
4/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.9%
6/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
General disorders
Oedema peripheral
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
4.4%
9/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
7.2%
15/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.9%
4/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Infections and infestations
Bronchitis
|
2.4%
5/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.4%
3/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.9%
4/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Infections and infestations
Influenza
|
1.9%
4/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.4%
5/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.5%
3/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
4/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.97%
2/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.9%
6/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
3.9%
8/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Infections and infestations
Sinusitis
|
4.8%
10/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.9%
6/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.9%
6/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
3.4%
7/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
9/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
5.8%
12/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.9%
6/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.9%
4/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Infections and infestations
Urinary tract infection
|
0.96%
2/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.9%
6/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
3.4%
7/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
3.4%
7/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
8/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.4%
5/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.96%
2/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.97%
2/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
3.9%
8/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.4%
3/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.9%
4/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
8/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
5.8%
12/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
6.7%
14/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.9%
6/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
4/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.4%
5/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.4%
3/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
3.4%
7/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.48%
1/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
3.4%
7/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
3.8%
8/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.4%
5/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.96%
2/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.9%
4/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.4%
5/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.97%
2/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
6/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.9%
6/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
9.6%
20/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.49%
1/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Nervous system disorders
Allodynia
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.4%
5/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.5%
3/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.4%
5/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Nervous system disorders
Dizziness
|
2.4%
5/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.9%
6/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.5%
3/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Nervous system disorders
Headache
|
5.3%
11/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
3.4%
7/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.4%
5/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
4.4%
9/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Nervous system disorders
Hypoaesthesia
|
0.96%
2/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.9%
4/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
4.8%
10/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
3.4%
7/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Nervous system disorders
Paraesthesia
|
1.4%
3/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
5.8%
12/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
8.7%
18/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.9%
6/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
1.5%
3/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
2.4%
5/208
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
0.00%
0/206
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Restriction Description: 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