Trial Outcomes & Findings for A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome (NCT NCT00999518)
NCT ID: NCT00999518
Last Updated: 2021-08-03
Results Overview
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
205 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2021-08-03
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
39
|
40
|
41
|
|
Overall Study
Treated
|
42
|
41
|
37
|
40
|
40
|
|
Overall Study
COMPLETED
|
19
|
17
|
17
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
24
|
25
|
22
|
22
|
24
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
6
|
3
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
4
|
1
|
|
Overall Study
Did not meet entrance criteria
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Study terminated by sponsor
|
10
|
6
|
5
|
5
|
9
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
10
|
6
|
1
|
|
Overall Study
Other
|
5
|
7
|
1
|
4
|
5
|
|
Overall Study
Randomized but not Treated
|
1
|
1
|
2
|
0
|
1
|
Baseline Characteristics
A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
Baseline characteristics by cohort
| Measure |
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Total
n=200 Participants
Total of all reporting groups
|
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 14.2 • n=21 Participants
|
48.1 years
STANDARD_DEVIATION 14.2 • n=8 Participants
|
51.4 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
47.2 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 14.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=21 Participants
|
170 Participants
n=8 Participants
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Average Daily Pain Score at Week 8
Baseline
|
5.38 units on a scale
Standard Deviation 1.259
|
5.72 units on a scale
Standard Deviation 1.337
|
6.01 units on a scale
Standard Deviation 1.381
|
5.76 units on a scale
Standard Deviation 1.669
|
6.08 units on a scale
Standard Deviation 1.288
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 8
Change at Week 8
|
-1.21 units on a scale
Standard Deviation 1.682
|
-1.16 units on a scale
Standard Deviation 1.760
|
-1.49 units on a scale
Standard Deviation 2.502
|
-1.60 units on a scale
Standard Deviation 2.175
|
-1.57 units on a scale
Standard Deviation 1.610
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=36 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=39 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 1
|
-0.45 units on a scale
Standard Deviation 1.100
|
-0.45 units on a scale
Standard Deviation 0.997
|
-0.83 units on a scale
Standard Deviation 1.715
|
-0.39 units on a scale
Standard Deviation 0.821
|
-0.43 units on a scale
Standard Deviation 1.055
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 2
|
-0.91 units on a scale
Standard Deviation 1.296
|
-0.55 units on a scale
Standard Deviation 1.151
|
-1.07 units on a scale
Standard Deviation 2.039
|
-0.73 units on a scale
Standard Deviation 1.450
|
-0.99 units on a scale
Standard Deviation 1.273
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 3
|
-1.14 units on a scale
Standard Deviation 1.521
|
-0.90 units on a scale
Standard Deviation 1.642
|
-1.09 units on a scale
Standard Deviation 2.135
|
-1.10 units on a scale
Standard Deviation 1.590
|
-1.17 units on a scale
Standard Deviation 1.283
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 4
|
-1.06 units on a scale
Standard Deviation 1.559
|
-1.14 units on a scale
Standard Deviation 1.797
|
-1.50 units on a scale
Standard Deviation 2.153
|
-1.41 units on a scale
Standard Deviation 1.789
|
-1.41 units on a scale
Standard Deviation 1.640
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 5
|
-1.18 units on a scale
Standard Deviation 1.576
|
-1.09 units on a scale
Standard Deviation 1.686
|
-1.51 units on a scale
Standard Deviation 2.121
|
-1.52 units on a scale
Standard Deviation 2.063
|
-1.56 units on a scale
Standard Deviation 1.456
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 6
|
-0.97 units on a scale
Standard Deviation 1.650
|
-1.43 units on a scale
Standard Deviation 1.815
|
-1.69 units on a scale
Standard Deviation 2.084
|
-1.42 units on a scale
Standard Deviation 2.074
|
-1.47 units on a scale
Standard Deviation 1.537
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 7
|
-1.18 units on a scale
Standard Deviation 1.814
|
-1.53 units on a scale
Standard Deviation 1.894
|
-1.67 units on a scale
Standard Deviation 2.308
|
-1.61 units on a scale
Standard Deviation 2.131
|
-1.66 units on a scale
Standard Deviation 1.770
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 9
|
-1.31 units on a scale
Standard Deviation 1.774
|
-1.62 units on a scale
Standard Deviation 1.844
|
-1.68 units on a scale
Standard Deviation 2.439
|
-1.74 units on a scale
Standard Deviation 2.219
|
-1.74 units on a scale
Standard Deviation 1.485
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 10
|
-1.42 units on a scale
Standard Deviation 1.881
|
-1.37 units on a scale
Standard Deviation 1.930
|
-1.95 units on a scale
Standard Deviation 2.628
|
-1.61 units on a scale
Standard Deviation 1.822
|
-1.98 units on a scale
Standard Deviation 1.779
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 11
|
-1.53 units on a scale
Standard Deviation 1.770
|
-1.41 units on a scale
Standard Deviation 1.961
|
-2.10 units on a scale
Standard Deviation 2.504
|
-1.85 units on a scale
Standard Deviation 2.502
|
-1.95 units on a scale
Standard Deviation 1.884
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 12
|
-1.62 units on a scale
Standard Deviation 1.598
|
-1.28 units on a scale
Standard Deviation 1.768
|
-1.93 units on a scale
Standard Deviation 2.177
|
-1.84 units on a scale
Standard Deviation 2.517
|
-1.94 units on a scale
Standard Deviation 1.630
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 13
|
-1.58 units on a scale
Standard Deviation 1.751
|
-1.47 units on a scale
Standard Deviation 1.944
|
-2.05 units on a scale
Standard Deviation 2.129
|
-1.83 units on a scale
Standard Deviation 2.374
|
-2.16 units on a scale
Standard Deviation 1.678
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 14
|
-1.56 units on a scale
Standard Deviation 1.882
|
-1.41 units on a scale
Standard Deviation 2.195
|
-1.86 units on a scale
Standard Deviation 1.988
|
-1.68 units on a scale
Standard Deviation 2.355
|
-1.85 units on a scale
Standard Deviation 1.760
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 15
|
-1.50 units on a scale
Standard Deviation 1.785
|
-1.81 units on a scale
Standard Deviation 1.710
|
-2.00 units on a scale
Standard Deviation 1.959
|
-1.68 units on a scale
Standard Deviation 2.399
|
-2.03 units on a scale
Standard Deviation 1.740
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 16
|
-1.75 units on a scale
Standard Deviation 1.728
|
-1.87 units on a scale
Standard Deviation 1.915
|
-2.39 units on a scale
Standard Deviation 2.546
|
-1.76 units on a scale
Standard Deviation 2.382
|
-2.29 units on a scale
Standard Deviation 1.630
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 17
|
-1.64 units on a scale
Standard Deviation 2.182
|
-1.85 units on a scale
Standard Deviation 1.882
|
-2.36 units on a scale
Standard Deviation 2.376
|
-1.95 units on a scale
Standard Deviation 2.282
|
-1.97 units on a scale
Standard Deviation 1.921
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 18
|
-1.47 units on a scale
Standard Deviation 2.248
|
-2.02 units on a scale
Standard Deviation 1.894
|
-2.85 units on a scale
Standard Deviation 2.521
|
-1.95 units on a scale
Standard Deviation 2.338
|
-1.98 units on a scale
Standard Deviation 1.855
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 19
|
-1.74 units on a scale
Standard Deviation 2.096
|
-2.65 units on a scale
Standard Deviation 1.508
|
-2.93 units on a scale
Standard Deviation 2.555
|
-1.86 units on a scale
Standard Deviation 2.498
|
-1.77 units on a scale
Standard Deviation 1.756
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 20
|
-1.71 units on a scale
Standard Deviation 2.207
|
-2.51 units on a scale
Standard Deviation 1.487
|
-2.18 units on a scale
Standard Deviation 2.226
|
-1.73 units on a scale
Standard Deviation 2.575
|
-1.96 units on a scale
Standard Deviation 1.896
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 21
|
-1.98 units on a scale
Standard Deviation 2.264
|
-2.76 units on a scale
Standard Deviation 1.515
|
-1.76 units on a scale
Standard Deviation 2.227
|
-1.99 units on a scale
Standard Deviation 2.542
|
-1.81 units on a scale
Standard Deviation 2.069
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 22
|
-1.85 units on a scale
Standard Deviation 2.380
|
-2.56 units on a scale
Standard Deviation 1.833
|
-1.75 units on a scale
Standard Deviation 2.626
|
-1.49 units on a scale
Standard Deviation 1.795
|
-1.97 units on a scale
Standard Deviation 1.941
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 23
|
-1.36 units on a scale
Standard Deviation 2.701
|
-2.12 units on a scale
Standard Deviation 2.012
|
-1.59 units on a scale
Standard Deviation 2.168
|
-1.20 units on a scale
Standard Deviation 1.647
|
-1.59 units on a scale
Standard Deviation 2.473
|
|
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Change at Week 24
|
-2.00 units on a scale
Standard Deviation 2.278
|
-2.11 units on a scale
Standard Deviation 2.083
|
-1.84 units on a scale
Standard Deviation 2.290
|
-0.94 units on a scale
Standard Deviation 1.625
|
-1.58 units on a scale
Standard Deviation 1.952
|
SECONDARY outcome
Timeframe: Week 8, 16Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Missing values were imputed using baseline observation carried forward (BOCF) method.
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score
Week 8: At least 30% Reduction
|
35.7 percentage of participants
|
26.8 percentage of participants
|
35.1 percentage of participants
|
35.0 percentage of participants
|
35.0 percentage of participants
|
|
Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score
Week 8: At least 50% Reduction
|
21.4 percentage of participants
|
14.6 percentage of participants
|
24.3 percentage of participants
|
25.0 percentage of participants
|
17.5 percentage of participants
|
|
Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score
Week 16: At least 30% Reduction
|
33.3 percentage of participants
|
31.7 percentage of participants
|
35.1 percentage of participants
|
27.5 percentage of participants
|
27.5 percentage of participants
|
|
Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score
Week 16: At least 50% Reduction
|
19.0 percentage of participants
|
17.1 percentage of participants
|
24.3 percentage of participants
|
15.0 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Worst daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their worst bladder pain due to IC/PBS over the past 24 hours on an 11-point NRS ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Baseline
|
6.84 units on a scale
Standard Deviation 1.341
|
7.29 units on a scale
Standard Deviation 1.489
|
7.32 units on a scale
Standard Deviation 1.263
|
7.15 units on a scale
Standard Deviation 1.342
|
7.41 units on a scale
Standard Deviation 1.334
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 1
|
-0.37 units on a scale
Standard Deviation 1.097
|
-0.45 units on a scale
Standard Deviation 1.038
|
-0.76 units on a scale
Standard Deviation 1.797
|
-0.33 units on a scale
Standard Deviation 0.966
|
-0.49 units on a scale
Standard Deviation 0.954
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 2
|
-0.84 units on a scale
Standard Deviation 1.363
|
-0.60 units on a scale
Standard Deviation 1.212
|
-0.98 units on a scale
Standard Deviation 2.078
|
-0.72 units on a scale
Standard Deviation 1.582
|
-0.98 units on a scale
Standard Deviation 1.230
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 3
|
-0.96 units on a scale
Standard Deviation 1.590
|
-0.80 units on a scale
Standard Deviation 1.785
|
-1.03 units on a scale
Standard Deviation 1.970
|
-1.07 units on a scale
Standard Deviation 1.788
|
-1.11 units on a scale
Standard Deviation 1.290
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 4
|
-0.87 units on a scale
Standard Deviation 1.660
|
-1.12 units on a scale
Standard Deviation 1.967
|
-1.36 units on a scale
Standard Deviation 2.083
|
-1.52 units on a scale
Standard Deviation 2.074
|
-1.42 units on a scale
Standard Deviation 1.853
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 5
|
-1.00 units on a scale
Standard Deviation 1.859
|
-1.13 units on a scale
Standard Deviation 1.712
|
-1.31 units on a scale
Standard Deviation 2.215
|
-1.71 units on a scale
Standard Deviation 2.306
|
-1.69 units on a scale
Standard Deviation 1.505
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 6
|
-0.85 units on a scale
Standard Deviation 1.784
|
-1.50 units on a scale
Standard Deviation 1.953
|
-1.53 units on a scale
Standard Deviation 2.321
|
-1.48 units on a scale
Standard Deviation 2.248
|
-1.53 units on a scale
Standard Deviation 1.715
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 7
|
-1.06 units on a scale
Standard Deviation 1.963
|
-1.59 units on a scale
Standard Deviation 2.163
|
-1.45 units on a scale
Standard Deviation 2.297
|
-1.77 units on a scale
Standard Deviation 2.324
|
-1.73 units on a scale
Standard Deviation 1.958
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 8
|
-1.20 units on a scale
Standard Deviation 1.927
|
-1.07 units on a scale
Standard Deviation 1.831
|
-1.30 units on a scale
Standard Deviation 2.462
|
-1.68 units on a scale
Standard Deviation 2.415
|
-1.78 units on a scale
Standard Deviation 1.751
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 9
|
-1.18 units on a scale
Standard Deviation 1.940
|
-1.32 units on a scale
Standard Deviation 2.227
|
-1.51 units on a scale
Standard Deviation 2.401
|
-1.74 units on a scale
Standard Deviation 2.501
|
-1.92 units on a scale
Standard Deviation 1.679
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 10
|
-1.30 units on a scale
Standard Deviation 2.050
|
-1.02 units on a scale
Standard Deviation 2.078
|
-1.95 units on a scale
Standard Deviation 2.449
|
-1.77 units on a scale
Standard Deviation 2.181
|
-2.13 units on a scale
Standard Deviation 2.000
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 11
|
-1.41 units on a scale
Standard Deviation 1.999
|
-1.31 units on a scale
Standard Deviation 2.185
|
-1.92 units on a scale
Standard Deviation 2.334
|
-2.00 units on a scale
Standard Deviation 2.677
|
-2.19 units on a scale
Standard Deviation 2.209
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 12
|
-1.56 units on a scale
Standard Deviation 1.836
|
-1.06 units on a scale
Standard Deviation 2.075
|
-1.73 units on a scale
Standard Deviation 2.175
|
-1.84 units on a scale
Standard Deviation 2.787
|
-2.06 units on a scale
Standard Deviation 2.056
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 13
|
-1.49 units on a scale
Standard Deviation 1.937
|
-1.20 units on a scale
Standard Deviation 2.109
|
-1.82 units on a scale
Standard Deviation 2.250
|
-1.86 units on a scale
Standard Deviation 2.617
|
-2.35 units on a scale
Standard Deviation 2.098
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 14
|
-1.49 units on a scale
Standard Deviation 1.982
|
-1.15 units on a scale
Standard Deviation 2.319
|
-1.54 units on a scale
Standard Deviation 1.903
|
-1.69 units on a scale
Standard Deviation 2.611
|
-2.00 units on a scale
Standard Deviation 2.116
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 15
|
-1.34 units on a scale
Standard Deviation 1.858
|
-1.40 units on a scale
Standard Deviation 2.138
|
-1.64 units on a scale
Standard Deviation 1.881
|
-1.80 units on a scale
Standard Deviation 2.608
|
-2.12 units on a scale
Standard Deviation 2.212
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 16
|
-1.66 units on a scale
Standard Deviation 1.878
|
-1.48 units on a scale
Standard Deviation 2.317
|
-2.21 units on a scale
Standard Deviation 2.405
|
-1.89 units on a scale
Standard Deviation 2.547
|
-2.39 units on a scale
Standard Deviation 2.107
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 17
|
-1.48 units on a scale
Standard Deviation 2.138
|
-1.27 units on a scale
Standard Deviation 2.339
|
-1.83 units on a scale
Standard Deviation 2.228
|
-1.93 units on a scale
Standard Deviation 2.568
|
-2.08 units on a scale
Standard Deviation 2.273
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 18
|
-1.34 units on a scale
Standard Deviation 2.066
|
-1.50 units on a scale
Standard Deviation 2.275
|
-2.53 units on a scale
Standard Deviation 2.530
|
-2.06 units on a scale
Standard Deviation 2.761
|
-1.99 units on a scale
Standard Deviation 2.105
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 19
|
-1.54 units on a scale
Standard Deviation 2.388
|
-1.92 units on a scale
Standard Deviation 2.827
|
-2.68 units on a scale
Standard Deviation 2.717
|
-1.92 units on a scale
Standard Deviation 2.916
|
-1.66 units on a scale
Standard Deviation 2.184
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 20
|
-1.42 units on a scale
Standard Deviation 2.318
|
-1.56 units on a scale
Standard Deviation 2.517
|
-1.79 units on a scale
Standard Deviation 2.393
|
-1.85 units on a scale
Standard Deviation 2.990
|
-1.85 units on a scale
Standard Deviation 2.068
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 21
|
-1.73 units on a scale
Standard Deviation 2.356
|
-1.81 units on a scale
Standard Deviation 2.344
|
-1.35 units on a scale
Standard Deviation 1.695
|
-2.24 units on a scale
Standard Deviation 2.975
|
-1.64 units on a scale
Standard Deviation 2.246
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 22
|
-1.69 units on a scale
Standard Deviation 2.674
|
-1.54 units on a scale
Standard Deviation 2.607
|
-1.46 units on a scale
Standard Deviation 2.425
|
-1.62 units on a scale
Standard Deviation 2.268
|
-1.82 units on a scale
Standard Deviation 2.103
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 23
|
-1.32 units on a scale
Standard Deviation 2.749
|
-1.01 units on a scale
Standard Deviation 2.686
|
-1.45 units on a scale
Standard Deviation 1.887
|
-1.20 units on a scale
Standard Deviation 1.821
|
-1.28 units on a scale
Standard Deviation 2.562
|
|
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Change at Week 24
|
-1.91 units on a scale
Standard Deviation 2.701
|
-0.80 units on a scale
Standard Deviation 2.695
|
-1.90 units on a scale
Standard Deviation 2.225
|
-0.93 units on a scale
Standard Deviation 1.738
|
-1.48 units on a scale
Standard Deviation 2.041
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 8, 16, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Participants answered: "Considering all the ways your bladder condition (IC/PBS) affects you, how are you doing today?" Participants responded on a 5-point scale where 1 = very good and 5 = very poor.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=35 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Patient Global Assessment of Health Status Scores
Baseline
|
3.1 units on a scale
Standard Deviation 0.58
|
3.1 units on a scale
Standard Deviation 0.66
|
3.5 units on a scale
Standard Deviation 0.82
|
3.1 units on a scale
Standard Deviation 0.61
|
3.1 units on a scale
Standard Deviation 0.76
|
|
Patient Global Assessment of Health Status Scores
Week 2
|
2.7 units on a scale
Standard Deviation 0.79
|
2.9 units on a scale
Standard Deviation 0.75
|
2.9 units on a scale
Standard Deviation 0.90
|
3.0 units on a scale
Standard Deviation 0.77
|
2.9 units on a scale
Standard Deviation 0.66
|
|
Patient Global Assessment of Health Status Scores
Week 8
|
2.9 units on a scale
Standard Deviation 0.70
|
2.9 units on a scale
Standard Deviation 0.94
|
2.9 units on a scale
Standard Deviation 0.93
|
2.9 units on a scale
Standard Deviation 0.83
|
2.9 units on a scale
Standard Deviation 0.90
|
|
Patient Global Assessment of Health Status Scores
Week 16
|
2.7 units on a scale
Standard Deviation 0.73
|
3.0 units on a scale
Standard Deviation 0.82
|
2.8 units on a scale
Standard Deviation 0.58
|
2.7 units on a scale
Standard Deviation 0.88
|
2.8 units on a scale
Standard Deviation 0.80
|
|
Patient Global Assessment of Health Status Scores
Week 24
|
2.7 units on a scale
Standard Deviation 0.89
|
2.6 units on a scale
Standard Deviation 0.62
|
2.5 units on a scale
Standard Deviation 0.94
|
2.8 units on a scale
Standard Deviation 0.79
|
3.4 units on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Week 8, 16, 24Population: ITT analysis set. Missing values were imputed using last observation carried forward (LOCF) method. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Participants were asked: "compared to when you began this trial, how would you rate your IC/PBS symptoms now?" Participants responded by using a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved.
Outcome measures
| Measure |
Placebo
n=38 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=28 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=33 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=34 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Participants With Global Response Assessment Scores
Week 8: Markedly Worse
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 8: Moderately Worse
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 8: Slightly Worse
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 8: No Change
|
13 Participants
|
13 Participants
|
7 Participants
|
11 Participants
|
14 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 8: Slightly Improved
|
8 Participants
|
12 Participants
|
6 Participants
|
9 Participants
|
11 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 8: Moderately Improved
|
8 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 8: Markedly Improved
|
3 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 16: Markedly Worse
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 16: Moderately Worse
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 16: Slightly Worse
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 16: No Change
|
9 Participants
|
12 Participants
|
8 Participants
|
9 Participants
|
13 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 16: Slightly Improved
|
10 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 16: Moderately Improved
|
3 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 16: Markedly Improved
|
6 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 24: Markedly Worse
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 24: Moderately Worse
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 24: Slightly Worse
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 24: No Change
|
7 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 24: Slightly Improved
|
4 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 24: Moderately Improved
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Global Response Assessment Scores
Week 24: Markedly Improved
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
The micturition frequency per 24 hours was calculated from the sum of voids divided by the diary period over which they were collected.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=39 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Micturitions Per 24 Hours
Baseline
|
12.98 micturitions per 24 hours
Standard Deviation 5.207
|
13.04 micturitions per 24 hours
Standard Deviation 5.500
|
14.12 micturitions per 24 hours
Standard Deviation 6.728
|
13.27 micturitions per 24 hours
Standard Deviation 5.403
|
13.13 micturitions per 24 hours
Standard Deviation 5.681
|
|
Number of Micturitions Per 24 Hours
Week 4
|
11.03 micturitions per 24 hours
Standard Deviation 4.867
|
11.81 micturitions per 24 hours
Standard Deviation 6.843
|
11.41 micturitions per 24 hours
Standard Deviation 5.735
|
10.62 micturitions per 24 hours
Standard Deviation 6.635
|
13.14 micturitions per 24 hours
Standard Deviation 7.930
|
|
Number of Micturitions Per 24 Hours
Week 8
|
11.61 micturitions per 24 hours
Standard Deviation 5.662
|
12.18 micturitions per 24 hours
Standard Deviation 6.675
|
10.39 micturitions per 24 hours
Standard Deviation 4.842
|
11.52 micturitions per 24 hours
Standard Deviation 7.009
|
11.13 micturitions per 24 hours
Standard Deviation 7.754
|
|
Number of Micturitions Per 24 Hours
Week 12
|
10.19 micturitions per 24 hours
Standard Deviation 5.265
|
12.88 micturitions per 24 hours
Standard Deviation 7.234
|
10.58 micturitions per 24 hours
Standard Deviation 4.933
|
10.21 micturitions per 24 hours
Standard Deviation 6.185
|
10.15 micturitions per 24 hours
Standard Deviation 5.695
|
|
Number of Micturitions Per 24 Hours
Week 16
|
9.24 micturitions per 24 hours
Standard Deviation 4.940
|
11.27 micturitions per 24 hours
Standard Deviation 4.892
|
10.93 micturitions per 24 hours
Standard Deviation 3.810
|
8.90 micturitions per 24 hours
Standard Deviation 6.212
|
9.99 micturitions per 24 hours
Standard Deviation 5.355
|
|
Number of Micturitions Per 24 Hours
Week 20
|
10.82 micturitions per 24 hours
Standard Deviation 6.034
|
12.11 micturitions per 24 hours
Standard Deviation 5.985
|
9.61 micturitions per 24 hours
Standard Deviation 4.987
|
10.17 micturitions per 24 hours
Standard Deviation 7.354
|
12.26 micturitions per 24 hours
Standard Deviation 7.272
|
|
Number of Micturitions Per 24 Hours
Week 24
|
11.10 micturitions per 24 hours
Standard Deviation 6.190
|
10.67 micturitions per 24 hours
Standard Deviation 5.871
|
10.67 micturitions per 24 hours
Standard Deviation 5.571
|
11.36 micturitions per 24 hours
Standard Deviation 5.575
|
11.04 micturitions per 24 hours
Standard Deviation 6.417
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
The nocturnal frequency per 24 hours was defined as the number of voids after going to bed and before getting up (the times of going to bed and getting up were recorded in the diary). The nocturnal micturition per 24 hours was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Nocturnal Micturitions Per 24 Hours
Baseline
|
2.63 micturitions per 24 hours
Standard Deviation 1.641
|
3.34 micturitions per 24 hours
Standard Deviation 2.379
|
2.66 micturitions per 24 hours
Standard Deviation 1.850
|
3.39 micturitions per 24 hours
Standard Deviation 2.667
|
2.95 micturitions per 24 hours
Standard Deviation 1.761
|
|
Number of Nocturnal Micturitions Per 24 Hours
Week 4
|
2.25 micturitions per 24 hours
Standard Deviation 1.634
|
3.40 micturitions per 24 hours
Standard Deviation 2.904
|
2.85 micturitions per 24 hours
Standard Deviation 1.720
|
2.44 micturitions per 24 hours
Standard Deviation 2.671
|
2.72 micturitions per 24 hours
Standard Deviation 2.601
|
|
Number of Nocturnal Micturitions Per 24 Hours
Week 8
|
2.58 micturitions per 24 hours
Standard Deviation 1.982
|
3.18 micturitions per 24 hours
Standard Deviation 2.094
|
2.44 micturitions per 24 hours
Standard Deviation 1.851
|
3.12 micturitions per 24 hours
Standard Deviation 3.316
|
2.73 micturitions per 24 hours
Standard Deviation 2.258
|
|
Number of Nocturnal Micturitions Per 24 Hours
Week 24
|
2.15 micturitions per 24 hours
Standard Deviation 1.693
|
3.45 micturitions per 24 hours
Standard Deviation 2.132
|
2.68 micturitions per 24 hours
Standard Deviation 1.426
|
3.39 micturitions per 24 hours
Standard Deviation 3.731
|
2.56 micturitions per 24 hours
Standard Deviation 1.891
|
|
Number of Nocturnal Micturitions Per 24 Hours
Week 12
|
1.97 micturitions per 24 hours
Standard Deviation 1.326
|
2.87 micturitions per 24 hours
Standard Deviation 2.023
|
2.62 micturitions per 24 hours
Standard Deviation 1.371
|
2.02 micturitions per 24 hours
Standard Deviation 2.106
|
2.71 micturitions per 24 hours
Standard Deviation 2.023
|
|
Number of Nocturnal Micturitions Per 24 Hours
Week 16
|
2.45 micturitions per 24 hours
Standard Deviation 3.141
|
3.55 micturitions per 24 hours
Standard Deviation 2.982
|
2.77 micturitions per 24 hours
Standard Deviation 1.456
|
2.17 micturitions per 24 hours
Standard Deviation 1.789
|
2.31 micturitions per 24 hours
Standard Deviation 1.949
|
|
Number of Nocturnal Micturitions Per 24 Hours
Week 20
|
2.95 micturitions per 24 hours
Standard Deviation 3.031
|
4.60 micturitions per 24 hours
Standard Deviation 4.302
|
2.29 micturitions per 24 hours
Standard Deviation 1.279
|
2.96 micturitions per 24 hours
Standard Deviation 2.937
|
3.89 micturitions per 24 hours
Standard Deviation 3.129
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
The micturition urgency frequency per 24 hours was calculated as the sum of urgency episodes (when participant had to rush to get to the bathroom to urinate) occurring during the diary period when this was measured, divided by the number of days over which they were recorded.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=39 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Micturition-related Urgency Episodes Per 24 Hours
Week 24
|
4.53 urgency episodes per 24 hours
Standard Deviation 6.286
|
3.65 urgency episodes per 24 hours
Standard Deviation 5.695
|
6.80 urgency episodes per 24 hours
Standard Deviation 6.568
|
6.62 urgency episodes per 24 hours
Standard Deviation 8.546
|
6.43 urgency episodes per 24 hours
Standard Deviation 7.734
|
|
Number of Micturition-related Urgency Episodes Per 24 Hours
Week 20
|
3.81 urgency episodes per 24 hours
Standard Deviation 5.482
|
4.62 urgency episodes per 24 hours
Standard Deviation 5.341
|
5.37 urgency episodes per 24 hours
Standard Deviation 5.840
|
5.09 urgency episodes per 24 hours
Standard Deviation 5.565
|
7.40 urgency episodes per 24 hours
Standard Deviation 8.167
|
|
Number of Micturition-related Urgency Episodes Per 24 Hours
Baseline
|
6.88 urgency episodes per 24 hours
Standard Deviation 6.721
|
7.04 urgency episodes per 24 hours
Standard Deviation 6.040
|
9.24 urgency episodes per 24 hours
Standard Deviation 7.665
|
8.38 urgency episodes per 24 hours
Standard Deviation 5.774
|
7.20 urgency episodes per 24 hours
Standard Deviation 6.842
|
|
Number of Micturition-related Urgency Episodes Per 24 Hours
Week 4
|
4.64 urgency episodes per 24 hours
Standard Deviation 5.680
|
6.90 urgency episodes per 24 hours
Standard Deviation 7.560
|
8.27 urgency episodes per 24 hours
Standard Deviation 10.391
|
5.97 urgency episodes per 24 hours
Standard Deviation 4.849
|
6.91 urgency episodes per 24 hours
Standard Deviation 8.820
|
|
Number of Micturition-related Urgency Episodes Per 24 Hours
Week 8
|
6.06 urgency episodes per 24 hours
Standard Deviation 7.493
|
6.50 urgency episodes per 24 hours
Standard Deviation 7.674
|
5.86 urgency episodes per 24 hours
Standard Deviation 5.213
|
6.51 urgency episodes per 24 hours
Standard Deviation 7.504
|
6.23 urgency episodes per 24 hours
Standard Deviation 8.625
|
|
Number of Micturition-related Urgency Episodes Per 24 Hours
Week 12
|
4.90 urgency episodes per 24 hours
Standard Deviation 6.575
|
5.73 urgency episodes per 24 hours
Standard Deviation 5.419
|
5.89 urgency episodes per 24 hours
Standard Deviation 5.035
|
5.09 urgency episodes per 24 hours
Standard Deviation 4.852
|
5.31 urgency episodes per 24 hours
Standard Deviation 6.597
|
|
Number of Micturition-related Urgency Episodes Per 24 Hours
Week 16
|
4.78 urgency episodes per 24 hours
Standard Deviation 6.254
|
5.06 urgency episodes per 24 hours
Standard Deviation 4.473
|
6.52 urgency episodes per 24 hours
Standard Deviation 6.374
|
4.34 urgency episodes per 24 hours
Standard Deviation 4.940
|
6.01 urgency episodes per 24 hours
Standard Deviation 6.511
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Participants completed 7-item questionnaire assessing their urge to urinate over the past 24 hours. The items were assessed on a 5-point response scale ranging from 0 (never) to 4 (always). Urge to urinate was calculated as the total of the 7 'urge' items with a minimum total score of 0 and a maximum total score of 28. Higher scores indicated greater symptom severity. An average was determined from the 3 days recorded in the 7-day diary period prior to each assessment time point.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Participant's Urge to Urinate
Week 12
|
13.21 units on a scale
Standard Deviation 6.010
|
15.64 units on a scale
Standard Deviation 6.904
|
13.75 units on a scale
Standard Deviation 6.376
|
14.43 units on a scale
Standard Deviation 5.635
|
14.02 units on a scale
Standard Deviation 7.761
|
|
Participant's Urge to Urinate
Baseline
|
15.63 units on a scale
Standard Deviation 4.313
|
17.04 units on a scale
Standard Deviation 5.015
|
18.95 units on a scale
Standard Deviation 4.750
|
17.73 units on a scale
Standard Deviation 3.794
|
17.11 units on a scale
Standard Deviation 5.011
|
|
Participant's Urge to Urinate
Week 4
|
13.75 units on a scale
Standard Deviation 5.871
|
16.27 units on a scale
Standard Deviation 5.990
|
14.87 units on a scale
Standard Deviation 5.750
|
15.71 units on a scale
Standard Deviation 4.699
|
14.83 units on a scale
Standard Deviation 6.234
|
|
Participant's Urge to Urinate
Week 8
|
14.81 units on a scale
Standard Deviation 4.951
|
15.80 units on a scale
Standard Deviation 6.338
|
14.71 units on a scale
Standard Deviation 6.297
|
14.38 units on a scale
Standard Deviation 4.804
|
13.81 units on a scale
Standard Deviation 6.830
|
|
Participant's Urge to Urinate
Week 16
|
13.59 units on a scale
Standard Deviation 5.589
|
14.28 units on a scale
Standard Deviation 6.083
|
13.49 units on a scale
Standard Deviation 6.223
|
14.05 units on a scale
Standard Deviation 5.812
|
13.85 units on a scale
Standard Deviation 8.156
|
|
Participant's Urge to Urinate
Week 20
|
14.05 units on a scale
Standard Deviation 5.729
|
12.75 units on a scale
Standard Deviation 7.124
|
11.95 units on a scale
Standard Deviation 7.226
|
13.97 units on a scale
Standard Deviation 5.887
|
15.62 units on a scale
Standard Deviation 9.020
|
|
Participant's Urge to Urinate
Week 24
|
12.39 units on a scale
Standard Deviation 7.258
|
13.25 units on a scale
Standard Deviation 6.489
|
11.13 units on a scale
Standard Deviation 7.442
|
14.28 units on a scale
Standard Deviation 4.870
|
15.87 units on a scale
Standard Deviation 8.800
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Mean volume voided per micturition was calculated as the total urine volume voided during the diary period when this was measured over 1 day, divided by the number of voids (with non missing volumes) during that day.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=38 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=39 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Mean Voided Volume Per Micturition
Baseline
|
142.12 milliliter
Standard Deviation 68.374
|
129.58 milliliter
Standard Deviation 57.649
|
122.78 milliliter
Standard Deviation 65.259
|
146.71 milliliter
Standard Deviation 71.013
|
139.92 milliliter
Standard Deviation 71.064
|
|
Mean Voided Volume Per Micturition
Week 4
|
130.75 milliliter
Standard Deviation 57.303
|
144.48 milliliter
Standard Deviation 110.219
|
117.45 milliliter
Standard Deviation 59.046
|
175.99 milliliter
Standard Deviation 97.418
|
140.84 milliliter
Standard Deviation 91.375
|
|
Mean Voided Volume Per Micturition
Week 8
|
132.33 milliliter
Standard Deviation 57.848
|
148.56 milliliter
Standard Deviation 109.210
|
165.02 milliliter
Standard Deviation 114.862
|
152.77 milliliter
Standard Deviation 86.116
|
155.09 milliliter
Standard Deviation 106.398
|
|
Mean Voided Volume Per Micturition
Week 12
|
136.60 milliliter
Standard Deviation 64.056
|
164.68 milliliter
Standard Deviation 180.771
|
136.06 milliliter
Standard Deviation 88.539
|
180.01 milliliter
Standard Deviation 85.147
|
158.35 milliliter
Standard Deviation 119.294
|
|
Mean Voided Volume Per Micturition
Week 16
|
141.39 milliliter
Standard Deviation 67.788
|
117.78 milliliter
Standard Deviation 75.291
|
112.86 milliliter
Standard Deviation 66.617
|
180.71 milliliter
Standard Deviation 88.065
|
163.20 milliliter
Standard Deviation 128.409
|
|
Mean Voided Volume Per Micturition
Week 20
|
131.52 milliliter
Standard Deviation 61.604
|
118.44 milliliter
Standard Deviation 68.203
|
139.61 milliliter
Standard Deviation 64.196
|
189.66 milliliter
Standard Deviation 86.580
|
135.80 milliliter
Standard Deviation 95.869
|
|
Mean Voided Volume Per Micturition
Week 24
|
138.77 milliliter
Standard Deviation 87.222
|
124.48 milliliter
Standard Deviation 76.990
|
152.99 milliliter
Standard Deviation 102.429
|
182.66 milliliter
Standard Deviation 95.542
|
174.96 milliliter
Standard Deviation 118.350
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 8, 16, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI was rated on a 0-5 scale. The sum of the individual question ratings was the total score for the ICSI. Total scores ranged from 0 to 20, with higher scores indicating greater symptom severity and bother.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=36 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=39 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Baseline
|
13.1 units on a scale
Standard Deviation 3.39
|
14.1 units on a scale
Standard Deviation 3.15
|
15.2 units on a scale
Standard Deviation 3.25
|
14.4 units on a scale
Standard Deviation 2.78
|
14.5 units on a scale
Standard Deviation 2.72
|
|
O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Week 8
|
11.4 units on a scale
Standard Deviation 3.26
|
12.7 units on a scale
Standard Deviation 4.44
|
12.6 units on a scale
Standard Deviation 5.06
|
12.2 units on a scale
Standard Deviation 4.23
|
12.2 units on a scale
Standard Deviation 4.70
|
|
O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Week 2
|
11.2 units on a scale
Standard Deviation 3.74
|
13.1 units on a scale
Standard Deviation 3.72
|
13.2 units on a scale
Standard Deviation 4.62
|
12.9 units on a scale
Standard Deviation 3.66
|
13.0 units on a scale
Standard Deviation 3.82
|
|
O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Week 16
|
10.8 units on a scale
Standard Deviation 4.22
|
13.4 units on a scale
Standard Deviation 3.77
|
12.5 units on a scale
Standard Deviation 4.47
|
11.5 units on a scale
Standard Deviation 4.89
|
12.3 units on a scale
Standard Deviation 4.92
|
|
O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Week 24
|
11.9 units on a scale
Standard Deviation 4.79
|
12.3 units on a scale
Standard Deviation 5.06
|
12.2 units on a scale
Standard Deviation 4.67
|
12.2 units on a scale
Standard Deviation 4.33
|
11.5 units on a scale
Standard Deviation 5.61
|
SECONDARY outcome
Timeframe: Baseline, Week 8, 16, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
BPI-sf is a 7-item self-administered questionnaire to assess the pain severity and pain interference on daily functions. Pain Severity Index (PSI) is an average of Questions 2-5 which measured the severity of pain (worst, least, average, right now) over past 24-hours on an 11-point scale (0=no pain to 10=pain as bad as you can imagine). Pain Interference Index (PII) is an average of 7 pain interference items of Question 7 that measured the level of interference of pain on daily function (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) on an 11-point scale (0=did not interfere to 10=completely interfered). Pain Severity Index and Pain Interference Index total scores ranged from 0 to 10, where higher scores indicate greater pain or greater interference.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=35 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Brief Pain Inventory-Short Form (BPI-sf) Score
Baseline: PSI
|
5.14 units on a scale
Standard Deviation 1.387
|
5.28 units on a scale
Standard Deviation 1.788
|
5.74 units on a scale
Standard Deviation 1.817
|
5.49 units on a scale
Standard Deviation 1.904
|
5.82 units on a scale
Standard Deviation 1.491
|
|
Brief Pain Inventory-Short Form (BPI-sf) Score
Baseline: PII
|
4.80 units on a scale
Standard Deviation 1.963
|
5.22 units on a scale
Standard Deviation 2.082
|
5.49 units on a scale
Standard Deviation 2.251
|
4.97 units on a scale
Standard Deviation 1.932
|
5.74 units on a scale
Standard Deviation 1.808
|
|
Brief Pain Inventory-Short Form (BPI-sf) Score
Week 8: PSI
|
4.12 units on a scale
Standard Deviation 2.072
|
4.28 units on a scale
Standard Deviation 2.090
|
4.84 units on a scale
Standard Deviation 2.318
|
4.30 units on a scale
Standard Deviation 2.293
|
4.60 units on a scale
Standard Deviation 1.984
|
|
Brief Pain Inventory-Short Form (BPI-sf) Score
Week 8: PII
|
3.76 units on a scale
Standard Deviation 2.432
|
4.49 units on a scale
Standard Deviation 2.607
|
4.46 units on a scale
Standard Deviation 2.980
|
3.93 units on a scale
Standard Deviation 2.513
|
4.61 units on a scale
Standard Deviation 2.598
|
|
Brief Pain Inventory-Short Form (BPI-sf) Score
Week 16: PSI
|
3.86 units on a scale
Standard Deviation 2.023
|
4.53 units on a scale
Standard Deviation 2.238
|
4.21 units on a scale
Standard Deviation 2.136
|
4.23 units on a scale
Standard Deviation 2.417
|
4.51 units on a scale
Standard Deviation 1.912
|
|
Brief Pain Inventory-Short Form (BPI-sf) Score
Week 16: PII
|
3.59 units on a scale
Standard Deviation 2.511
|
4.67 units on a scale
Standard Deviation 2.552
|
4.52 units on a scale
Standard Deviation 2.715
|
3.87 units on a scale
Standard Deviation 2.600
|
4.31 units on a scale
Standard Deviation 2.467
|
|
Brief Pain Inventory-Short Form (BPI-sf) Score
Week 24: PSI
|
3.96 units on a scale
Standard Deviation 2.159
|
3.16 units on a scale
Standard Deviation 1.871
|
3.99 units on a scale
Standard Deviation 2.376
|
4.57 units on a scale
Standard Deviation 2.001
|
5.16 units on a scale
Standard Deviation 1.879
|
|
Brief Pain Inventory-Short Form (BPI-sf) Score
Week 24, PII
|
4.16 units on a scale
Standard Deviation 2.153
|
3.53 units on a scale
Standard Deviation 2.739
|
4.48 units on a scale
Standard Deviation 3.149
|
4.54 units on a scale
Standard Deviation 2.246
|
4.39 units on a scale
Standard Deviation 2.699
|
SECONDARY outcome
Timeframe: Week 8, 16, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "Overall, how satisfied are you with the drug that you received since you entered this trial?" Participant's response is rated on a 5-point scale where 1=extremely dissatisfied (dissatisf), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied. Number of participants with each response is reported.
Outcome measures
| Measure |
Placebo
n=38 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=36 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=28 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=32 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=34 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 24: Satisfied
|
4 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 24: Satisfy/Dissatisfy
|
7 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 24: Dissatisfied
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 24: Extremely Dissatisf
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 8: Extremely Satisfied
|
5 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 8: Satisfied
|
12 Participants
|
11 Participants
|
8 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 8: Satisfy/Dissatisfy
|
14 Participants
|
14 Participants
|
6 Participants
|
17 Participants
|
11 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 8: Dissatisfied
|
6 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 8: Extremely Dissatisf
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 16: Extremely Satisfied
|
3 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 16: Satisfied
|
12 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week16: Satisfy/Dissatisfy
|
11 Participants
|
10 Participants
|
8 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 16: Dissatisfied
|
6 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 16: Extremely Dissatisf
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Patient Global Satisfaction Assessment Scores
Week 24: Extremely Satisfied
|
6 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 8, 16, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Participant global preference is assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment (T/T), preference and willingness to continue using study medication. Participant reported previous T/T under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery, and no T/T. Participant preference was assessed on a 5-point scale where, 1=No, I definitely prefer my prior T/T (Def Pref Prior), 2=I have a slight preference for my prior T/T (Slight Pref Prior T/T), 3=I have no preference either way (No preference), 4=I have a slight preference for the drug that I am receiving now (Slight Pref Current), 5=Yes, I definitely prefer the drug that I am receiving (Def Pref Current Drug) now. Number of participants under each of the categories is reported. For previous T/T, a single participant may be represented in more than 1 category.
Outcome measures
| Measure |
Placebo
n=38 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=36 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=28 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=32 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=34 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Participants With Patient Global Preference Assessment Score
Week 8: Lifestyle Interventions
|
16 Participants
|
17 Participants
|
16 Participants
|
17 Participants
|
14 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 8: Physical Therapies
|
8 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 8: Toileting Programs
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 8: Drug Given Into Bladder
|
7 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
11 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 8: Drug Taken by Mouth
|
24 Participants
|
20 Participants
|
17 Participants
|
22 Participants
|
20 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 8: Surgery
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 8: No Treatment
|
6 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 8: Def Pref Current Drug
|
9 Participants
|
11 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 8:Slight Pref Current
|
9 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
10 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 8: No Preference
|
14 Participants
|
12 Participants
|
8 Participants
|
15 Participants
|
10 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week8:Slight Pref Prior T/T
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 8: Def Pref Prior
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 16:Lifestyle Interventions
|
15 Participants
|
14 Participants
|
9 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 16: Physical Therapies
|
6 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 16: Toileting Programs
|
2 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 16:Drug Given Into Bladder
|
5 Participants
|
8 Participants
|
9 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 16: Drug Taken by Mouth
|
21 Participants
|
17 Participants
|
11 Participants
|
16 Participants
|
16 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 16: Surgery
|
5 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 16: No Treatment
|
6 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 16: Def Pref Current Drug
|
8 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 16:Slight Pref Current
|
7 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 16: No Preference
|
16 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week16:Slight Pref Prior T/T
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 16:Def Pref Prior
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 24:Lifestyle Interventions
|
8 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 24: Physical Therapies
|
6 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 24: Toileting Programs
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 24:Drug Given Into Bladder
|
3 Participants
|
4 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 24: Drug Taken by Mouth
|
12 Participants
|
9 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 24: Surgery
|
1 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 24: No Treatment
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 24: Def Pref Current Drug
|
6 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 24:Slight Pref Current
|
4 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 24: No Preference
|
7 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 24: Slight Pref Prior T/T
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Global Preference Assessment Score
Week 24:Def Pref Prior
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 8, 16, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Participant willingness to re-use study medication is assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "In the future, would you be willing to use the same drug that you have received since you entered this trial for your chronic prostatitis?" Participants responded on 5-point scale where, 1=No, I definitely would not want to use the same drug again (definitely not want), 2=I might not want to use the same drug again (might not want), 3=I am not sure (not sure), 4=I might want to use the same drug again (might want), 5=Yes, I would definitely want to use the same drug again (definitely want).
Outcome measures
| Measure |
Placebo
n=38 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=36 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=28 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=32 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=33 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 16: Definitely Want
|
3 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 16: Might Want
|
12 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 16: Not Sure
|
11 Participants
|
10 Participants
|
8 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 8: Definitely Want
|
12 Participants
|
12 Participants
|
10 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 16: Might not Want
|
6 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 16: Definitely not Want
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 8: Might Want
|
11 Participants
|
10 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 8: Not Sure
|
13 Participants
|
11 Participants
|
7 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 8: Might not Want
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 8: Definitely not Want
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 24: Definitely not Want
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 24: Definitely Want
|
6 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 24: Might Want
|
4 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 24: Not Sure
|
4 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Willingness to Re-use Medicine Assessment
Week 24: Might not Want
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8, 16, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=35 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=39 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score
Week 24
|
0.74 units on a scale
Standard Deviation 0.174
|
0.76 units on a scale
Standard Deviation 0.187
|
0.72 units on a scale
Standard Deviation 0.232
|
0.67 units on a scale
Standard Deviation 0.202
|
0.66 units on a scale
Standard Deviation 0.252
|
|
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score
Baseline
|
0.69 units on a scale
Standard Deviation 0.209
|
0.68 units on a scale
Standard Deviation 0.182
|
0.56 units on a scale
Standard Deviation 0.233
|
0.70 units on a scale
Standard Deviation 0.167
|
0.61 units on a scale
Standard Deviation 0.224
|
|
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score
Week 8
|
0.74 units on a scale
Standard Deviation 0.235
|
0.73 units on a scale
Standard Deviation 0.191
|
0.69 units on a scale
Standard Deviation 0.214
|
0.70 units on a scale
Standard Deviation 0.185
|
0.68 units on a scale
Standard Deviation 0.233
|
|
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score
Week 16
|
0.75 units on a scale
Standard Deviation 0.221
|
0.71 units on a scale
Standard Deviation 0.187
|
0.72 units on a scale
Standard Deviation 0.162
|
0.77 units on a scale
Standard Deviation 0.124
|
0.73 units on a scale
Standard Deviation 0.215
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 8, 16, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
PBIC-QoL: 25-item questionnaire to assess impact of IC/PBS on health related quality of life over past 7 days. PBIC-QoL included 17 items (Items 2, 5, 8, 11, 14, 18, 20 and 21 did not form part of final instrument), of which 13 were divided into 3 dimensions: activity limitations (Items 1, 3, 4, 6, 7), impact on emotional wellbeing (Items 13, 15, 16, 17, 19), impact on sleep (Items 22, 23, 24). Four items: Item 9 (impact on going out with friends), Item 10 (impact on concentration), Item 12 (impact on eating and drinking), Item 25 (impact on sex life) were scored separately to dimension scores as single items. Items were scored from 4 'not at all' to 0 'extremely difficult' or 'a very great deal'. Eight items included a 'not applicable' response option. Dimension scores ranged from 0 to 4, higher score indicate better quality of life. Total score=sum of the dimension and single item scores, ranged from 0 to 28, higher score indicated better quality of life.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=31 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=27 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=25 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=30 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score
Baseline
|
11.49 units on a scale
Standard Deviation 4.774
|
10.56 units on a scale
Standard Deviation 4.147
|
10.39 units on a scale
Standard Deviation 5.531
|
11.44 units on a scale
Standard Deviation 3.938
|
10.42 units on a scale
Standard Deviation 5.172
|
|
Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score
Week 2
|
16.41 units on a scale
Standard Deviation 5.784
|
12.79 units on a scale
Standard Deviation 5.173
|
13.77 units on a scale
Standard Deviation 6.953
|
15.34 units on a scale
Standard Deviation 5.895
|
13.24 units on a scale
Standard Deviation 6.093
|
|
Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score
Week 8
|
16.47 units on a scale
Standard Deviation 5.256
|
12.02 units on a scale
Standard Deviation 5.594
|
15.26 units on a scale
Standard Deviation 7.272
|
14.42 units on a scale
Standard Deviation 6.635
|
14.10 units on a scale
Standard Deviation 6.606
|
|
Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score
Week 16
|
16.49 units on a scale
Standard Deviation 6.180
|
11.19 units on a scale
Standard Deviation 4.486
|
15.21 units on a scale
Standard Deviation 6.671
|
17.23 units on a scale
Standard Deviation 5.868
|
13.94 units on a scale
Standard Deviation 7.153
|
|
Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score
Week 24
|
14.27 units on a scale
Standard Deviation 7.808
|
14.45 units on a scale
Standard Deviation 5.663
|
16.77 units on a scale
Standard Deviation 8.044
|
14.27 units on a scale
Standard Deviation 5.813
|
15.05 units on a scale
Standard Deviation 6.852
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication.
For inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Received Rescue Medication
Baseline
|
52.4 percentage of participants
|
65.9 percentage of participants
|
56.8 percentage of participants
|
50.0 percentage of participants
|
57.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 1
|
42.9 percentage of participants
|
53.7 percentage of participants
|
48.6 percentage of participants
|
50.0 percentage of participants
|
42.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 2
|
50.0 percentage of participants
|
53.7 percentage of participants
|
54.1 percentage of participants
|
57.5 percentage of participants
|
42.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 3
|
35.7 percentage of participants
|
51.2 percentage of participants
|
48.6 percentage of participants
|
47.5 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 4
|
33.3 percentage of participants
|
53.7 percentage of participants
|
43.2 percentage of participants
|
45.0 percentage of participants
|
45.0 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 5
|
33.3 percentage of participants
|
39.0 percentage of participants
|
40.5 percentage of participants
|
40.0 percentage of participants
|
45.0 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 6
|
35.7 percentage of participants
|
48.8 percentage of participants
|
37.8 percentage of participants
|
42.5 percentage of participants
|
32.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 7
|
38.1 percentage of participants
|
26.8 percentage of participants
|
37.8 percentage of participants
|
35.0 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 8
|
35.7 percentage of participants
|
34.1 percentage of participants
|
35.1 percentage of participants
|
30.0 percentage of participants
|
35.0 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 9
|
31.0 percentage of participants
|
31.7 percentage of participants
|
37.8 percentage of participants
|
30.0 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 10
|
35.7 percentage of participants
|
34.1 percentage of participants
|
29.7 percentage of participants
|
22.5 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 11
|
31.0 percentage of participants
|
26.8 percentage of participants
|
29.7 percentage of participants
|
25.0 percentage of participants
|
32.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 12
|
26.2 percentage of participants
|
24.4 percentage of participants
|
24.3 percentage of participants
|
27.5 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 13
|
31.0 percentage of participants
|
24.4 percentage of participants
|
24.3 percentage of participants
|
22.5 percentage of participants
|
27.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 14
|
31.0 percentage of participants
|
24.4 percentage of participants
|
21.6 percentage of participants
|
25.0 percentage of participants
|
32.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 15
|
28.6 percentage of participants
|
17.1 percentage of participants
|
27.0 percentage of participants
|
22.5 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 16
|
19.0 percentage of participants
|
14.6 percentage of participants
|
18.9 percentage of participants
|
25.0 percentage of participants
|
17.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 17
|
21.4 percentage of participants
|
17.1 percentage of participants
|
18.9 percentage of participants
|
22.5 percentage of participants
|
22.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 18
|
19.0 percentage of participants
|
17.1 percentage of participants
|
16.2 percentage of participants
|
17.5 percentage of participants
|
15.0 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 19
|
21.4 percentage of participants
|
19.5 percentage of participants
|
13.5 percentage of participants
|
17.5 percentage of participants
|
17.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 20
|
14.3 percentage of participants
|
12.2 percentage of participants
|
21.6 percentage of participants
|
17.5 percentage of participants
|
15.0 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 21
|
14.3 percentage of participants
|
12.2 percentage of participants
|
18.9 percentage of participants
|
20.0 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 22
|
19.0 percentage of participants
|
14.6 percentage of participants
|
10.8 percentage of participants
|
10.8 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 23
|
19.0 percentage of participants
|
12.2 percentage of participants
|
10.8 percentage of participants
|
10.0 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants Who Received Rescue Medication
Week 24
|
14.3 percentage of participants
|
7.3 percentage of participants
|
5.4 percentage of participants
|
10.0 percentage of participants
|
7.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=27 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=21 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=23 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=23 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Days of Rescue Medication Usage Per Week
Baseline
|
4.1 days per week
Standard Deviation 2.18
|
3.6 days per week
Standard Deviation 2.39
|
3.8 days per week
Standard Deviation 2.27
|
4.1 days per week
Standard Deviation 2.36
|
4.6 days per week
Standard Deviation 2.08
|
|
Number of Days of Rescue Medication Usage Per Week
Week 1
|
4.5 days per week
Standard Deviation 2.38
|
4.0 days per week
Standard Deviation 2.21
|
3.8 days per week
Standard Deviation 2.32
|
4.6 days per week
Standard Deviation 2.01
|
4.8 days per week
Standard Deviation 1.68
|
|
Number of Days of Rescue Medication Usage Per Week
Week 2
|
3.4 days per week
Standard Deviation 2.56
|
3.9 days per week
Standard Deviation 2.25
|
3.6 days per week
Standard Deviation 2.42
|
3.7 days per week
Standard Deviation 2.38
|
4.2 days per week
Standard Deviation 2.31
|
|
Number of Days of Rescue Medication Usage Per Week
Week 3
|
3.5 days per week
Standard Deviation 2.50
|
3.5 days per week
Standard Deviation 2.38
|
3.9 days per week
Standard Deviation 2.49
|
3.6 days per week
Standard Deviation 2.27
|
4.3 days per week
Standard Deviation 2.27
|
|
Number of Days of Rescue Medication Usage Per Week
Week 4
|
3.3 days per week
Standard Deviation 2.46
|
3.5 days per week
Standard Deviation 2.42
|
3.1 days per week
Standard Deviation 2.35
|
3.7 days per week
Standard Deviation 2.40
|
3.9 days per week
Standard Deviation 2.63
|
|
Number of Days of Rescue Medication Usage Per Week
Week 5
|
3.6 days per week
Standard Deviation 2.37
|
4.6 days per week
Standard Deviation 2.19
|
3.9 days per week
Standard Deviation 2.66
|
3.3 days per week
Standard Deviation 2.57
|
4.2 days per week
Standard Deviation 2.53
|
|
Number of Days of Rescue Medication Usage Per Week
Week 6
|
3.7 days per week
Standard Deviation 2.32
|
3.3 days per week
Standard Deviation 2.20
|
3.8 days per week
Standard Deviation 2.22
|
2.22 days per week
Standard Deviation 2.33
|
4.5 days per week
Standard Deviation 2.60
|
|
Number of Days of Rescue Medication Usage Per Week
Week 7
|
3.7 days per week
Standard Deviation 2.30
|
5.0 days per week
Standard Deviation 2.00
|
3.9 days per week
Standard Deviation 2.37
|
3.5 days per week
Standard Deviation 2.38
|
4.5 days per week
Standard Deviation 2.36
|
|
Number of Days of Rescue Medication Usage Per Week
Week 8
|
4.0 days per week
Standard Deviation 2.07
|
4.6 days per week
Standard Deviation 1.91
|
3.8 days per week
Standard Deviation 2.58
|
3.6 days per week
Standard Deviation 2.61
|
4.3 days per week
Standard Deviation 2.05
|
|
Number of Days of Rescue Medication Usage Per Week
Week 9
|
4.2 days per week
Standard Deviation 1.74
|
4.6 days per week
Standard Deviation 1.76
|
4.1 days per week
Standard Deviation 2.37
|
4.1 days per week
Standard Deviation 2.43
|
3.8 days per week
Standard Deviation 2.37
|
|
Number of Days of Rescue Medication Usage Per Week
Week 10
|
3.1 days per week
Standard Deviation 1.92
|
3.7 days per week
Standard Deviation 2.05
|
4.4 days per week
Standard Deviation 2.46
|
4.2 days per week
Standard Deviation 2.86
|
4.3 days per week
Standard Deviation 2.46
|
|
Number of Days of Rescue Medication Usage Per Week
Week 11
|
4.2 days per week
Standard Deviation 2.24
|
4.0 days per week
Standard Deviation 2.41
|
4.2 days per week
Standard Deviation 2.32
|
3.9 days per week
Standard Deviation 2.64
|
4.1 days per week
Standard Deviation 2.60
|
|
Number of Days of Rescue Medication Usage Per Week
Week 12
|
3.6 days per week
Standard Deviation 2.01
|
4.6 days per week
Standard Deviation 1.90
|
5.0 days per week
Standard Deviation 2.50
|
4.1 days per week
Standard Deviation 2.43
|
3.8 days per week
Standard Deviation 2.41
|
|
Number of Days of Rescue Medication Usage Per Week
Week 13
|
3.2 days per week
Standard Deviation 2.08
|
4.3 days per week
Standard Deviation 1.64
|
4.7 days per week
Standard Deviation 2.83
|
4.8 days per week
Standard Deviation 2.28
|
4.5 days per week
Standard Deviation 2.21
|
|
Number of Days of Rescue Medication Usage Per Week
Week 14
|
3.7 days per week
Standard Deviation 2.46
|
3.8 days per week
Standard Deviation 2.25
|
4.6 days per week
Standard Deviation 2.07
|
4.3 days per week
Standard Deviation 2.58
|
4.1 days per week
Standard Deviation 2.36
|
|
Number of Days of Rescue Medication Usage Per Week
Week 15
|
3.2 days per week
Standard Deviation 2.17
|
4.0 days per week
Standard Deviation 2.58
|
3.6 days per week
Standard Deviation 2.59
|
3.3 days per week
Standard Deviation 2.40
|
5.0 days per week
Standard Deviation 2.00
|
|
Number of Days of Rescue Medication Usage Per Week
Week 16
|
3.5 days per week
Standard Deviation 1.93
|
4.7 days per week
Standard Deviation 2.16
|
4.1 days per week
Standard Deviation 1.95
|
3.9 days per week
Standard Deviation 2.81
|
4.6 days per week
Standard Deviation 1.27
|
|
Number of Days of Rescue Medication Usage Per Week
Week 17
|
3.7 days per week
Standard Deviation 2.45
|
3.3 days per week
Standard Deviation 2.29
|
4.4 days per week
Standard Deviation 2.15
|
3.4 days per week
Standard Deviation 2.46
|
3.7 days per week
Standard Deviation 2.18
|
|
Number of Days of Rescue Medication Usage Per Week
Week 18
|
3.6 days per week
Standard Deviation 2.00
|
3.3 days per week
Standard Deviation 1.60
|
4.5 days per week
Standard Deviation 1.64
|
3.1 days per week
Standard Deviation 2.67
|
4.7 days per week
Standard Deviation 2.42
|
|
Number of Days of Rescue Medication Usage Per Week
Week 19
|
3.9 days per week
Standard Deviation 2.37
|
2.5 days per week
Standard Deviation 1.41
|
4.6 days per week
Standard Deviation 2.51
|
3.7 days per week
Standard Deviation 2.43
|
3.6 days per week
Standard Deviation 2.57
|
|
Number of Days of Rescue Medication Usage Per Week
Week 20
|
4.8 days per week
Standard Deviation 1.72
|
3.2 days per week
Standard Deviation 2.59
|
4.0 days per week
Standard Deviation 2.39
|
3.3 days per week
Standard Deviation 1.98
|
4.0 days per week
Standard Deviation 2.37
|
|
Number of Days of Rescue Medication Usage Per Week
Week 21
|
3.8 days per week
Standard Deviation 2.40
|
3.4 days per week
Standard Deviation 2.51
|
2.3 days per week
Standard Deviation 1.38
|
2.4 days per week
Standard Deviation 2.13
|
5.7 days per week
Standard Deviation 1.53
|
|
Number of Days of Rescue Medication Usage Per Week
Week 22
|
3.4 days per week
Standard Deviation 1.69
|
3.2 days per week
Standard Deviation 2.14
|
4.3 days per week
Standard Deviation 2.75
|
3.2 days per week
Standard Deviation 2.14
|
4.7 days per week
Standard Deviation 3.21
|
|
Number of Days of Rescue Medication Usage Per Week
Week 23
|
4.5 days per week
Standard Deviation 2.07
|
3.6 days per week
Standard Deviation 2.30
|
4.3 days per week
Standard Deviation 2.06
|
2.8 days per week
Standard Deviation 2.22
|
4.7 days per week
Standard Deviation 3.21
|
|
Number of Days of Rescue Medication Usage Per Week
Week 24
|
4.5 days per week
Standard Deviation 2.51
|
4.0 days per week
Standard Deviation 2.00
|
7.0 days per week
Standard Deviation 0.00
|
3.3 days per week
Standard Deviation 2.87
|
5.7 days per week
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Rescue Medication Doses Used Per Week
Baseline
|
4.09 doses per week
Standard Deviation 2.18
|
3.56 doses per week
Standard Deviation 2.39
|
3.81 doses per week
Standard Deviation 2.27
|
4.10 doses per week
Standard Deviation 2.36
|
4.61 doses per week
Standard Deviation 2.08
|
|
Number of Rescue Medication Doses Used Per Week
Week 1
|
4.50 doses per week
Standard Deviation 2.38
|
4.05 doses per week
Standard Deviation 2.21
|
3.78 doses per week
Standard Deviation 2.32
|
4.55 doses per week
Standard Deviation 2.01
|
4.76 doses per week
Standard Deviation 1.68
|
|
Number of Rescue Medication Doses Used Per Week
Week 2
|
3.43 doses per week
Standard Deviation 2.56
|
3.86 doses per week
Standard Deviation 2.25
|
3.55 doses per week
Standard Deviation 2.42
|
3.70 doses per week
Standard Deviation 2.38
|
4.24 doses per week
Standard Deviation 2.31
|
|
Number of Rescue Medication Doses Used Per Week
Week 3
|
3.53 doses per week
Standard Deviation 2.50
|
3.48 doses per week
Standard Deviation 2.38
|
3.89 doses per week
Standard Deviation 2.49
|
3.58 doses per week
Standard Deviation 2.27
|
4.31 doses per week
Standard Deviation 2.27
|
|
Number of Rescue Medication Doses Used Per Week
Week 4
|
3.29 doses per week
Standard Deviation 2.46
|
3.45 doses per week
Standard Deviation 2.42
|
3.06 doses per week
Standard Deviation 2.35
|
3.67 doses per week
Standard Deviation 2.40
|
3.89 doses per week
Standard Deviation 2.63
|
|
Number of Rescue Medication Doses Used Per Week
Week 5
|
3.64 doses per week
Standard Deviation 2.37
|
4.56 doses per week
Standard Deviation 2.19
|
3.93 doses per week
Standard Deviation 2.66
|
3.25 doses per week
Standard Deviation 2.57
|
4.22 doses per week
Standard Deviation 2.53
|
|
Number of Rescue Medication Doses Used Per Week
Week 6
|
3.67 doses per week
Standard Deviation 2.32
|
3.25 doses per week
Standard Deviation 2.20
|
3.79 doses per week
Standard Deviation 2.22
|
3.06 doses per week
Standard Deviation 2.33
|
4.54 doses per week
Standard Deviation 2.60
|
|
Number of Rescue Medication Doses Used Per Week
Week 7
|
3.69 doses per week
Standard Deviation 2.30
|
5.00 doses per week
Standard Deviation 2.00
|
3.93 doses per week
Standard Deviation 2.37
|
3.50 doses per week
Standard Deviation 2.38
|
4.47 doses per week
Standard Deviation 2.36
|
|
Number of Rescue Medication Doses Used Per Week
Week 8
|
4.00 doses per week
Standard Deviation 2.07
|
4.57 doses per week
Standard Deviation 1.91
|
3.85 doses per week
Standard Deviation 2.58
|
3.58 doses per week
Standard Deviation 2.61
|
4.29 doses per week
Standard Deviation 2.05
|
|
Number of Rescue Medication Doses Used Per Week
Week 9
|
4.23 doses per week
Standard Deviation 1.74
|
4.62 doses per week
Standard Deviation 1.76
|
4.07 doses per week
Standard Deviation 2.37
|
4.08 doses per week
Standard Deviation 2.43
|
3.83 doses per week
Standard Deviation 2.37
|
|
Number of Rescue Medication Doses Used Per Week
Week 10
|
3.13 doses per week
Standard Deviation 1.92
|
3.71 doses per week
Standard Deviation 2.05
|
4.36 doses per week
Standard Deviation 2.46
|
4.22 doses per week
Standard Deviation 2.86
|
4.33 doses per week
Standard Deviation 2.46
|
|
Number of Rescue Medication Doses Used Per Week
Week 11
|
4.23 doses per week
Standard Deviation 2.24
|
4.00 doses per week
Standard Deviation 2.41
|
4.18 doses per week
Standard Deviation 2.32
|
3.90 doses per week
Standard Deviation 2.64
|
4.08 doses per week
Standard Deviation 2.60
|
|
Number of Rescue Medication Doses Used Per Week
Week 12
|
3.64 doses per week
Standard Deviation 2.01
|
4.60 doses per week
Standard Deviation 1.90
|
5.00 doses per week
Standard Deviation 2.50
|
4.09 doses per week
Standard Deviation 2.43
|
3.83 doses per week
Standard Deviation 2.41
|
|
Number of Rescue Medication Doses Used Per Week
Week 13
|
3.15 doses per week
Standard Deviation 2.08
|
4.30 doses per week
Standard Deviation 1.64
|
4.67 doses per week
Standard Deviation 2.83
|
4.78 doses per week
Standard Deviation 2.28
|
4.45 doses per week
Standard Deviation 2.21
|
|
Number of Rescue Medication Doses Used Per Week
Week 14
|
3.69 doses per week
Standard Deviation 2.46
|
3.80 doses per week
Standard Deviation 2.25
|
4.63 doses per week
Standard Deviation 2.07
|
4.30 doses per week
Standard Deviation 2.58
|
4.08 doses per week
Standard Deviation 2.36
|
|
Number of Rescue Medication Doses Used Per Week
Week 15
|
3.17 doses per week
Standard Deviation 2.17
|
4.00 doses per week
Standard Deviation 2.58
|
3.60 doses per week
Standard Deviation 2.59
|
3.33 doses per week
Standard Deviation 2.40
|
5.00 doses per week
Standard Deviation 2.00
|
|
Number of Rescue Medication Doses Used Per Week
Week 16
|
3.50 doses per week
Standard Deviation 1.93
|
4.67 doses per week
Standard Deviation 2.16
|
4.14 doses per week
Standard Deviation 1.95
|
3.90 doses per week
Standard Deviation 2.81
|
4.57 doses per week
Standard Deviation 1.27
|
|
Number of Rescue Medication Doses Used Per Week
Week 17
|
3.67 doses per week
Standard Deviation 2.45
|
3.29 doses per week
Standard Deviation 2.29
|
4.43 doses per week
Standard Deviation 2.15
|
3.44 doses per week
Standard Deviation 2.46
|
3.67 doses per week
Standard Deviation 2.18
|
|
Number of Rescue Medication Doses Used Per Week
Week 18
|
3.63 doses per week
Standard Deviation 2.00
|
3.29 doses per week
Standard Deviation 1.60
|
4.50 doses per week
Standard Deviation 1.64
|
3.14 doses per week
Standard Deviation 2.67
|
4.67 doses per week
Standard Deviation 2.42
|
|
Number of Rescue Medication Doses Used Per Week
Week 19
|
3.89 doses per week
Standard Deviation 2.37
|
2.50 doses per week
Standard Deviation 1.41
|
4.60 doses per week
Standard Deviation 2.51
|
3.71 doses per week
Standard Deviation 2.43
|
3.57 doses per week
Standard Deviation 2.57
|
|
Number of Rescue Medication Doses Used Per Week
Week 20
|
4.83 doses per week
Standard Deviation 1.72
|
3.20 doses per week
Standard Deviation 2.59
|
4.00 doses per week
Standard Deviation 2.39
|
3.29 doses per week
Standard Deviation 1.98
|
4.00 doses per week
Standard Deviation 2.37
|
|
Number of Rescue Medication Doses Used Per Week
Week 21
|
3.83 doses per week
Standard Deviation 2.40
|
3.40 doses per week
Standard Deviation 2.51
|
2.29 doses per week
Standard Deviation 1.38
|
2.38 doses per week
Standard Deviation 2.13
|
5.67 doses per week
Standard Deviation 1.53
|
|
Number of Rescue Medication Doses Used Per Week
Week 22
|
3.38 doses per week
Standard Deviation 1.69
|
3.17 doses per week
Standard Deviation 2.14
|
4.25 doses per week
Standard Deviation 2.75
|
3.17 doses per week
Standard Deviation 2.14
|
4.67 doses per week
Standard Deviation 3.21
|
|
Number of Rescue Medication Doses Used Per Week
Week 23
|
4.50 doses per week
Standard Deviation 2.07
|
3.60 doses per week
Standard Deviation 2.30
|
4.25 doses per week
Standard Deviation 2.06
|
2.75 doses per week
Standard Deviation 2.22
|
4.67 doses per week
Standard Deviation 3.21
|
|
Number of Rescue Medication Doses Used Per Week
Week 24
|
4.50 doses per week
Standard Deviation 2.51
|
4.00 doses per week
Standard Deviation 2.00
|
7.00 doses per week
Standard Deviation 0.00
|
3.25 doses per week
Standard Deviation 2.87
|
5.67 doses per week
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
In case of inadequate pain relief or worsening symptoms of IC/PBS, acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) could be taken as rescue medication.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=27 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=21 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=20 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=23 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Amount of Rescue Medication Taken Per Week
Baseline
|
5827.3 mg/week
Standard Deviation 4485.87
|
4781.5 mg/week
Standard Deviation 4596.49
|
5428.6 mg/week
Standard Deviation 4688.51
|
5875.0 mg/week
Standard Deviation 4795.49
|
5695.7 mg/week
Standard Deviation 4255.32
|
|
Amount of Rescue Medication Taken Per Week
Week 1
|
5527.8 mg/week
Standard Deviation 3908.78
|
5090.9 mg/week
Standard Deviation 4055.09
|
5444.4 mg/week
Standard Deviation 6125.86
|
6375.0 mg/week
Standard Deviation 4737.52
|
6058.8 mg/week
Standard Deviation 3273.39
|
|
Amount of Rescue Medication Taken Per Week
Week 2
|
4333.3 mg/week
Standard Deviation 4749.56
|
4590.9 mg/week
Standard Deviation 4052.15
|
5300.0 mg/week
Standard Deviation 5795.64
|
5369.6 mg/week
Standard Deviation 5341.13
|
5647.1 mg/week
Standard Deviation 4018.57
|
|
Amount of Rescue Medication Taken Per Week
Week 3
|
4573.3 mg/week
Standard Deviation 4831.66
|
4190.5 mg/week
Standard Deviation 3838.87
|
5861.1 mg/week
Standard Deviation 5232.27
|
5368.4 mg/week
Standard Deviation 4669.17
|
6218.8 mg/week
Standard Deviation 4837.25
|
|
Amount of Rescue Medication Taken Per Week
Week 4
|
4371.4 mg/week
Standard Deviation 4431.60
|
4013.6 mg/week
Standard Deviation 4024.84
|
4312.5 mg/week
Standard Deviation 4003.64
|
5500.0 mg/week
Standard Deviation 5787.92
|
5194.4 mg/week
Standard Deviation 4765.50
|
|
Amount of Rescue Medication Taken Per Week
Week 5
|
4342.9 mg/week
Standard Deviation 4300.22
|
5625.0 mg/week
Standard Deviation 4368.45
|
5866.7 mg/week
Standard Deviation 5569.26
|
4843.8 mg/week
Standard Deviation 5545.93
|
5694.4 mg/week
Standard Deviation 4902.40
|
|
Amount of Rescue Medication Taken Per Week
Week 6
|
4873.3 mg/week
Standard Deviation 4005.08
|
3320.0 mg/week
Standard Deviation 2758.83
|
5178.6 mg/week
Standard Deviation 4846.12
|
4735.3 mg/week
Standard Deviation 6200.09
|
6500.0 mg/week
Standard Deviation 4267.12
|
|
Amount of Rescue Medication Taken Per Week
Week 7
|
5181.3 mg/week
Standard Deviation 4803.36
|
6181.8 mg/week
Standard Deviation 3363.57
|
5392.9 mg/week
Standard Deviation 4637.55
|
4928.6 mg/week
Standard Deviation 5473.21
|
6500.0 mg/week
Standard Deviation 4263.63
|
|
Amount of Rescue Medication Taken Per Week
Week 8
|
4740.0 mg/week
Standard Deviation 2844.74
|
6071.4 mg/week
Standard Deviation 4367.08
|
6307.7 mg/week
Standard Deviation 6223.40
|
5875.0 mg/week
Standard Deviation 6045.75
|
6428.6 mg/week
Standard Deviation 4807.27
|
|
Amount of Rescue Medication Taken Per Week
Week 9
|
5238.5 mg/week
Standard Deviation 2722.91
|
6884.6 mg/week
Standard Deviation 5838.64
|
6464.3 mg/week
Standard Deviation 6203.18
|
6166.7 mg/week
Standard Deviation 6087.74
|
5958.3 mg/week
Standard Deviation 5565.55
|
|
Amount of Rescue Medication Taken Per Week
Week 10
|
4266.7 mg/week
Standard Deviation 3272.54
|
4785.7 mg/week
Standard Deviation 4259.44
|
7181.8 mg/week
Standard Deviation 5934.11
|
6333.3 mg/week
Standard Deviation 6359.05
|
6916.7 mg/week
Standard Deviation 5418.12
|
|
Amount of Rescue Medication Taken Per Week
Week 11
|
5538.5 mg/week
Standard Deviation 3078.57
|
5681.8 mg/week
Standard Deviation 5316.36
|
5500.0 mg/week
Standard Deviation 4398.86
|
5750.0 mg/week
Standard Deviation 5422.43
|
6807.7 mg/week
Standard Deviation 7084.43
|
|
Amount of Rescue Medication Taken Per Week
Week 12
|
4954.5 mg/week
Standard Deviation 3791.14
|
6250.0 mg/week
Standard Deviation 5731.25
|
6333.3 mg/week
Standard Deviation 3848.70
|
7500.0 mg/week
Standard Deviation 7861.30
|
5583.3 mg/week
Standard Deviation 5142.66
|
|
Amount of Rescue Medication Taken Per Week
Week 13
|
6500.0 mg/week
Standard Deviation 8638.58
|
5800.0 mg/week
Standard Deviation 4211.10
|
6777.8 mg/week
Standard Deviation 5810.07
|
6888.9 mg/week
Standard Deviation 6406.92
|
6772.7 mg/week
Standard Deviation 4808.14
|
|
Amount of Rescue Medication Taken Per Week
Week 14
|
6269.2 mg/week
Standard Deviation 5666.48
|
5250.0 mg/week
Standard Deviation 4184.96
|
5562.5 mg/week
Standard Deviation 3310.56
|
6250.0 mg/week
Standard Deviation 6161.03
|
6807.7 mg/week
Standard Deviation 5717.44
|
|
Amount of Rescue Medication Taken Per Week
Week 15
|
5083.3 mg/week
Standard Deviation 4655.56
|
8214.3 mg/week
Standard Deviation 8489.49
|
4700.0 mg/week
Standard Deviation 4601.93
|
7333.3 mg/week
Standard Deviation 8437.27
|
6500.0 mg/week
Standard Deviation 3909.69
|
|
Amount of Rescue Medication Taken Per Week
Week 16
|
5375.0 mg/week
Standard Deviation 4332.19
|
6083.3 mg/week
Standard Deviation 3292.67
|
5500.0 mg/week
Standard Deviation 3807.89
|
6900.0 mg/week
Standard Deviation 6814.20
|
6142.9 mg/week
Standard Deviation 2925.67
|
|
Amount of Rescue Medication Taken Per Week
Week 17
|
6000.0 mg/week
Standard Deviation 5454.36
|
3571.4 mg/week
Standard Deviation 3207.13
|
6000.0 mg/week
Standard Deviation 4133.20
|
4722.2 mg/week
Standard Deviation 3392.19
|
6111.1 mg/week
Standard Deviation 6303.66
|
|
Amount of Rescue Medication Taken Per Week
Week 18
|
6437.5 mg/week
Standard Deviation 6038.20
|
3285.7 mg/week
Standard Deviation 2766.72
|
6583.3 mg/week
Standard Deviation 4128.16
|
3714.3 mg/week
Standard Deviation 3672.61
|
5583.3 mg/week
Standard Deviation 4079.42
|
|
Amount of Rescue Medication Taken Per Week
Week 19
|
6500.0 mg/week
Standard Deviation 4242.64
|
4250.0 mg/week
Standard Deviation 4157.61
|
6400.0 mg/week
Standard Deviation 5042.32
|
4214.3 mg/week
Standard Deviation 3717.72
|
4214.3 mg/week
Standard Deviation 4270.61
|
|
Amount of Rescue Medication Taken Per Week
Week 20
|
7333.3 mg/week
Standard Deviation 4191.26
|
3300.0 mg/week
Standard Deviation 3290.14
|
5375.0 mg/week
Standard Deviation 4413.86
|
3714.3 mg/week
Standard Deviation 3186.65
|
5000.0 mg/week
Standard Deviation 5167.20
|
|
Amount of Rescue Medication Taken Per Week
Week 21
|
6333.3 mg/week
Standard Deviation 4792.36
|
3600.0 mg/week
Standard Deviation 3595.14
|
2428.6 mg/week
Standard Deviation 1592.39
|
2750.0 mg/week
Standard Deviation 2563.48
|
7333.3 mg/week
Standard Deviation 7333.3
|
|
Amount of Rescue Medication Taken Per Week
Week 22
|
5625.0 mg/week
Standard Deviation 3482.10
|
2750.0 mg/week
Standard Deviation 2715.70
|
5375.0 mg/week
Standard Deviation 4534.59
|
5250.0 mg/week
Standard Deviation 3489.27
|
6000.0 mg/week
Standard Deviation 4582.58
|
|
Amount of Rescue Medication Taken Per Week
Week 23
|
8375.0 mg/week
Standard Deviation 5566.16
|
3300.0 mg/week
Standard Deviation 2841.65
|
4500.0 mg/week
Standard Deviation 2886.75
|
3125.0 mg/week
Standard Deviation 1931.11
|
6666.7 mg/week
Standard Deviation 5507.57
|
|
Amount of Rescue Medication Taken Per Week
Week 24
|
7500.0 mg/week
Standard Deviation 4560.70
|
3166.7 mg/week
Standard Deviation 2020.73
|
6000.0 mg/week
Standard Deviation 2121.32
|
3625.0 mg/week
Standard Deviation 2780.14
|
8500.0 mg/week
Standard Deviation 5766.28
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 8, 16, 24Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Serum samples were analyzed for total NGF using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric method (IA/LC/MS/MS) method.
Outcome measures
| Measure |
Placebo
n=40 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=39 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=36 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Serum Total Nerve Growth Factor (NGF) Levels
Baseline
|
41.756 picogram per milliliter (pg/mL)
Standard Deviation 11.5576
|
39.929 picogram per milliliter (pg/mL)
Standard Deviation 10.7855
|
37.209 picogram per milliliter (pg/mL)
Standard Deviation 8.4699
|
38.381 picogram per milliliter (pg/mL)
Standard Deviation 11.0441
|
38.150 picogram per milliliter (pg/mL)
Standard Deviation 7.6355
|
|
Serum Total Nerve Growth Factor (NGF) Levels
Week 1
|
39.260 picogram per milliliter (pg/mL)
Standard Deviation 13.2510
|
552.485 picogram per milliliter (pg/mL)
Standard Deviation 221.4202
|
730.917 picogram per milliliter (pg/mL)
Standard Deviation 253.8217
|
1034.317 picogram per milliliter (pg/mL)
Standard Deviation 221.8687
|
1113.780 picogram per milliliter (pg/mL)
Standard Deviation 307.0217
|
|
Serum Total Nerve Growth Factor (NGF) Levels
Week 2
|
40.162 picogram per milliliter (pg/mL)
Standard Deviation 10.1141
|
901.633 picogram per milliliter (pg/mL)
Standard Deviation 335.4488
|
1242.388 picogram per milliliter (pg/mL)
Standard Deviation 425.2031
|
1644.283 picogram per milliliter (pg/mL)
Standard Deviation 396.6413
|
1812.559 picogram per milliliter (pg/mL)
Standard Deviation 530.0335
|
|
Serum Total Nerve Growth Factor (NGF) Levels
Week 8
|
58.075 picogram per milliliter (pg/mL)
Standard Deviation 103.6542
|
841.984 picogram per milliliter (pg/mL)
Standard Deviation 446.1437
|
1545.148 picogram per milliliter (pg/mL)
Standard Deviation 770.2641
|
2502.127 picogram per milliliter (pg/mL)
Standard Deviation 833.8403
|
3369.039 picogram per milliliter (pg/mL)
Standard Deviation 1795.1505
|
|
Serum Total Nerve Growth Factor (NGF) Levels
Week 16
|
48.207 picogram per milliliter (pg/mL)
Standard Deviation 28.6793
|
590.896 picogram per milliliter (pg/mL)
Standard Deviation 638.2373
|
1079.050 picogram per milliliter (pg/mL)
Standard Deviation 803.0958
|
3171.980 picogram per milliliter (pg/mL)
Standard Deviation 1205.2251
|
3497.462 picogram per milliliter (pg/mL)
Standard Deviation 2837.0678
|
|
Serum Total Nerve Growth Factor (NGF) Levels
Week 24
|
40.626 picogram per milliliter (pg/mL)
Standard Deviation 8.9706
|
131.474 picogram per milliliter (pg/mL)
Standard Deviation 123.8849
|
321.928 picogram per milliliter (pg/mL)
Standard Deviation 331.1179
|
2153.000 picogram per milliliter (pg/mL)
Standard Deviation 929.5347
|
3137.829 picogram per milliliter (pg/mL)
Standard Deviation 3612.2725
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 2, 8, 16, Week 24 or early terminationPopulation: ITT analysis set. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
A neurological examination assessed the strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=39 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=39 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Participants With Neurological Examination Findings
Week 16
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Neurological Examination Findings
Week 2
|
1 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Neurological Examination Findings
Week 8
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Neurological Examination Findings
Week 24 or early termination
|
1 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 2, 8, 16, 24Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
The NIS constituted the sum of 37 standard items of neuromuscular examination used to assess the muscle strength, reflexes and sensation. Each item was scored separately for left and right sides. Components of muscle weakness (24 items) were scored on a scale from 0 (normal) to 4 (paralysis), with higher score = more weakness; components of reflexes and sensation (13 items) scored on a scale with 0 = normal, 1 = decreased or 2 = absent. Total NIS score ranged from 0 to 244, a higher score indicate more impairment.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24
Baseline
|
1.0 units on a scale
Standard Deviation 3.46
|
0.4 units on a scale
Standard Deviation 0.92
|
0.9 units on a scale
Standard Deviation 3.10
|
0.9 units on a scale
Standard Deviation 2.87
|
0.3 units on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24
Change at Week 2
|
-0.7 units on a scale
Standard Deviation 3.45
|
0.2 units on a scale
Standard Deviation 0.86
|
0.2 units on a scale
Standard Deviation 1.32
|
0.9 units on a scale
Standard Deviation 2.88
|
-0.0 units on a scale
Standard Deviation 0.16
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24
Change at Week 8
|
-0.5 units on a scale
Standard Deviation 3.53
|
0.3 units on a scale
Standard Deviation 1.38
|
-0.1 units on a scale
Standard Deviation 0.47
|
1.1 units on a scale
Standard Deviation 5.28
|
0.0 units on a scale
Standard Deviation 0.41
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24
Change at Week 16
|
-0.1 units on a scale
Standard Deviation 0.43
|
-0.3 units on a scale
Standard Deviation 0.66
|
0.3 units on a scale
Standard Deviation 1.16
|
1.4 units on a scale
Standard Deviation 6.33
|
0.1 units on a scale
Standard Deviation 0.23
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24
Change at Week 24
|
-0.4 units on a scale
Standard Deviation 1.75
|
-0.1 units on a scale
Standard Deviation 0.63
|
-0.6 units on a scale
Standard Deviation 1.74
|
0.7 units on a scale
Standard Deviation 5.15
|
0.1 units on a scale
Standard Deviation 0.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Body Temperature
Week 8 (1 hour post-dose)
|
36.57 degree Celsius
Standard Deviation 0.307
|
36.63 degree Celsius
Standard Deviation 0.301
|
36.60 degree Celsius
Standard Deviation 0.350
|
36.45 degree Celsius
Standard Deviation 0.244
|
36.66 degree Celsius
Standard Deviation 0.305
|
|
Body Temperature
Screening
|
36.56 degree Celsius
Standard Deviation 0.323
|
36.71 degree Celsius
Standard Deviation 0.304
|
36.56 degree Celsius
Standard Deviation 0.363
|
36.58 degree Celsius
Standard Deviation 0.341
|
36.67 degree Celsius
Standard Deviation 0.328
|
|
Body Temperature
Day 1 (1 hour pre-dose)
|
36.56 degree Celsius
Standard Deviation 0.359
|
36.62 degree Celsius
Standard Deviation 0.327
|
36.64 degree Celsius
Standard Deviation 0.321
|
36.55 degree Celsius
Standard Deviation 0.362
|
36.57 degree Celsius
Standard Deviation 0.246
|
|
Body Temperature
Day 1 (1 hour post-dose)
|
36.46 degree Celsius
Standard Deviation 0.306
|
36.55 degree Celsius
Standard Deviation 0.372
|
36.65 degree Celsius
Standard Deviation 0.304
|
36.50 degree Celsius
Standard Deviation 0.364
|
36.58 degree Celsius
Standard Deviation 0.322
|
|
Body Temperature
Week 1
|
36.57 degree Celsius
Standard Deviation 0.338
|
36.67 degree Celsius
Standard Deviation 0.351
|
36.52 degree Celsius
Standard Deviation 0.349
|
36.58 degree Celsius
Standard Deviation 0.317
|
36.48 degree Celsius
Standard Deviation 0.351
|
|
Body Temperature
Week 2
|
36.56 degree Celsius
Standard Deviation 0.397
|
36.57 degree Celsius
Standard Deviation 0.401
|
36.55 degree Celsius
Standard Deviation 0.376
|
36.63 degree Celsius
Standard Deviation 0.360
|
36.54 degree Celsius
Standard Deviation 0.294
|
|
Body Temperature
Week 8 (1 hour pre-dose)
|
36.56 degree Celsius
Standard Deviation 0.321
|
36.59 degree Celsius
Standard Deviation 0.285
|
36.66 degree Celsius
Standard Deviation 0.342
|
36.58 degree Celsius
Standard Deviation 0.339
|
36.60 degree Celsius
Standard Deviation 0.350
|
|
Body Temperature
Week 16
|
36.53 degree Celsius
Standard Deviation 0.353
|
36.66 degree Celsius
Standard Deviation 0.398
|
36.64 degree Celsius
Standard Deviation 0.341
|
36.37 degree Celsius
Standard Deviation 0.299
|
36.71 degree Celsius
Standard Deviation 0.251
|
|
Body Temperature
Week 24
|
36.60 degree Celsius
Standard Deviation 0.387
|
36.63 degree Celsius
Standard Deviation 0.411
|
36.53 degree Celsius
Standard Deviation 0.368
|
36.53 degree Celsius
Standard Deviation 0.325
|
36.60 degree Celsius
Standard Deviation 0.300
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Systolic and Diastolic Blood Pressure
Day 1(1 hour post-dose): DBP
|
74.2 millimeter of mercury (mmHg)
Standard Deviation 9.41
|
74.5 millimeter of mercury (mmHg)
Standard Deviation 8.77
|
73.8 millimeter of mercury (mmHg)
Standard Deviation 11.72
|
74.8 millimeter of mercury (mmHg)
Standard Deviation 9.05
|
76.8 millimeter of mercury (mmHg)
Standard Deviation 8.65
|
|
Systolic and Diastolic Blood Pressure
Week 1: SBP
|
124.6 millimeter of mercury (mmHg)
Standard Deviation 17.29
|
117.4 millimeter of mercury (mmHg)
Standard Deviation 14.44
|
116.8 millimeter of mercury (mmHg)
Standard Deviation 12.07
|
117.9 millimeter of mercury (mmHg)
Standard Deviation 13.35
|
119.4 millimeter of mercury (mmHg)
Standard Deviation 12.44
|
|
Systolic and Diastolic Blood Pressure
Week 1: DBP
|
74.9 millimeter of mercury (mmHg)
Standard Deviation 11.27
|
72.6 millimeter of mercury (mmHg)
Standard Deviation 9.42
|
74.7 millimeter of mercury (mmHg)
Standard Deviation 9.69
|
71.6 millimeter of mercury (mmHg)
Standard Deviation 9.88
|
73.9 millimeter of mercury (mmHg)
Standard Deviation 10.32
|
|
Systolic and Diastolic Blood Pressure
Week 2: SBP
|
124.4 millimeter of mercury (mmHg)
Standard Deviation 14.26
|
113.3 millimeter of mercury (mmHg)
Standard Deviation 11.82
|
118.8 millimeter of mercury (mmHg)
Standard Deviation 13.47
|
122.0 millimeter of mercury (mmHg)
Standard Deviation 16.45
|
118.2 millimeter of mercury (mmHg)
Standard Deviation 12.53
|
|
Systolic and Diastolic Blood Pressure
Week 2: DBP
|
74.8 millimeter of mercury (mmHg)
Standard Deviation 8.85
|
71.3 millimeter of mercury (mmHg)
Standard Deviation 8.46
|
76.8 millimeter of mercury (mmHg)
Standard Deviation 8.99
|
74.5 millimeter of mercury (mmHg)
Standard Deviation 9.44
|
72.4 millimeter of mercury (mmHg)
Standard Deviation 9.15
|
|
Systolic and Diastolic Blood Pressure
Week 8(1 hour pre-dose): SBP
|
120.1 millimeter of mercury (mmHg)
Standard Deviation 12.64
|
115.1 millimeter of mercury (mmHg)
Standard Deviation 13.42
|
117.0 millimeter of mercury (mmHg)
Standard Deviation 14.06
|
122.4 millimeter of mercury (mmHg)
Standard Deviation 17.13
|
113.4 millimeter of mercury (mmHg)
Standard Deviation 11.83
|
|
Systolic and Diastolic Blood Pressure
Week 8(1 hour pre-dose): DBP
|
73.8 millimeter of mercury (mmHg)
Standard Deviation 9.07
|
73.5 millimeter of mercury (mmHg)
Standard Deviation 9.93
|
72.0 millimeter of mercury (mmHg)
Standard Deviation 7.08
|
73.4 millimeter of mercury (mmHg)
Standard Deviation 9.73
|
71.5 millimeter of mercury (mmHg)
Standard Deviation 7.98
|
|
Systolic and Diastolic Blood Pressure
Week 8(1 hour post-dose): SBP
|
123.0 millimeter of mercury (mmHg)
Standard Deviation 12.39
|
111.8 millimeter of mercury (mmHg)
Standard Deviation 11.12
|
119.1 millimeter of mercury (mmHg)
Standard Deviation 9.18
|
120.7 millimeter of mercury (mmHg)
Standard Deviation 17.35
|
118.8 millimeter of mercury (mmHg)
Standard Deviation 9.98
|
|
Systolic and Diastolic Blood Pressure
Week 8(1 hour post-dose): DBP
|
73.9 millimeter of mercury (mmHg)
Standard Deviation 7.71
|
69.9 millimeter of mercury (mmHg)
Standard Deviation 8.63
|
75.2 millimeter of mercury (mmHg)
Standard Deviation 6.07
|
74.8 millimeter of mercury (mmHg)
Standard Deviation 9.34
|
73.8 millimeter of mercury (mmHg)
Standard Deviation 6.15
|
|
Systolic and Diastolic Blood Pressure
Week 16: SBP
|
125.4 millimeter of mercury (mmHg)
Standard Deviation 17.72
|
117.4 millimeter of mercury (mmHg)
Standard Deviation 13.72
|
119.7 millimeter of mercury (mmHg)
Standard Deviation 13.63
|
121.8 millimeter of mercury (mmHg)
Standard Deviation 14.89
|
115.8 millimeter of mercury (mmHg)
Standard Deviation 10.33
|
|
Systolic and Diastolic Blood Pressure
Week 16: DBP
|
75.3 millimeter of mercury (mmHg)
Standard Deviation 10.51
|
71.2 millimeter of mercury (mmHg)
Standard Deviation 8.24
|
72.8 millimeter of mercury (mmHg)
Standard Deviation 12.69
|
75.7 millimeter of mercury (mmHg)
Standard Deviation 12.15
|
71.2 millimeter of mercury (mmHg)
Standard Deviation 9.94
|
|
Systolic and Diastolic Blood Pressure
Week 24: SBP
|
124.3 millimeter of mercury (mmHg)
Standard Deviation 16.37
|
118.3 millimeter of mercury (mmHg)
Standard Deviation 12.06
|
122.1 millimeter of mercury (mmHg)
Standard Deviation 12.78
|
122.4 millimeter of mercury (mmHg)
Standard Deviation 17.38
|
120.0 millimeter of mercury (mmHg)
Standard Deviation 12.43
|
|
Systolic and Diastolic Blood Pressure
Week 24: DBP
|
77.6 millimeter of mercury (mmHg)
Standard Deviation 9.66
|
71.9 millimeter of mercury (mmHg)
Standard Deviation 10.13
|
78.1 millimeter of mercury (mmHg)
Standard Deviation 8.58
|
73.8 millimeter of mercury (mmHg)
Standard Deviation 10.05
|
74.1 millimeter of mercury (mmHg)
Standard Deviation 7.70
|
|
Systolic and Diastolic Blood Pressure
Screening: SBP
|
126.3 millimeter of mercury (mmHg)
Standard Deviation 15.95
|
118.5 millimeter of mercury (mmHg)
Standard Deviation 14.15
|
121.3 millimeter of mercury (mmHg)
Standard Deviation 12.25
|
123.5 millimeter of mercury (mmHg)
Standard Deviation 12.40
|
123.2 millimeter of mercury (mmHg)
Standard Deviation 13.39
|
|
Systolic and Diastolic Blood Pressure
Screening: DBP
|
75.4 millimeter of mercury (mmHg)
Standard Deviation 11.46
|
73.4 millimeter of mercury (mmHg)
Standard Deviation 9.05
|
76.4 millimeter of mercury (mmHg)
Standard Deviation 9.46
|
76.8 millimeter of mercury (mmHg)
Standard Deviation 10.35
|
75.0 millimeter of mercury (mmHg)
Standard Deviation 9.34
|
|
Systolic and Diastolic Blood Pressure
Day 1 (1 hour pre-dose): SBP
|
125.8 millimeter of mercury (mmHg)
Standard Deviation 16.81
|
118.0 millimeter of mercury (mmHg)
Standard Deviation 13.88
|
119.4 millimeter of mercury (mmHg)
Standard Deviation 12.02
|
121.1 millimeter of mercury (mmHg)
Standard Deviation 14.86
|
121.3 millimeter of mercury (mmHg)
Standard Deviation 12.75
|
|
Systolic and Diastolic Blood Pressure
Day 1 (1 hour pre-dose): DBP
|
75.9 millimeter of mercury (mmHg)
Standard Deviation 10.13
|
73.1 millimeter of mercury (mmHg)
Standard Deviation 8.60
|
75.9 millimeter of mercury (mmHg)
Standard Deviation 10.61
|
74.5 millimeter of mercury (mmHg)
Standard Deviation 10.02
|
75.5 millimeter of mercury (mmHg)
Standard Deviation 9.47
|
|
Systolic and Diastolic Blood Pressure
Day 1(1 hour post-dose): SBP
|
125.0 millimeter of mercury (mmHg)
Standard Deviation 13.06
|
118.5 millimeter of mercury (mmHg)
Standard Deviation 12.41
|
121.5 millimeter of mercury (mmHg)
Standard Deviation 12.78
|
123.4 millimeter of mercury (mmHg)
Standard Deviation 15.02
|
122.7 millimeter of mercury (mmHg)
Standard Deviation 14.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Heart Rate
Screening
|
74.7 beats per minute
Standard Deviation 10.37
|
76.4 beats per minute
Standard Deviation 10.40
|
75.0 beats per minute
Standard Deviation 12.72
|
74.2 beats per minute
Standard Deviation 15.22
|
75.5 beats per minute
Standard Deviation 11.81
|
|
Heart Rate
Day 1 (1 hour pre-dose)
|
75.4 beats per minute
Standard Deviation 10.45
|
77.5 beats per minute
Standard Deviation 10.86
|
75.5 beats per minute
Standard Deviation 12.06
|
73.6 beats per minute
Standard Deviation 14.03
|
76.5 beats per minute
Standard Deviation 11.17
|
|
Heart Rate
Day 1 (1 hour post-dose)
|
75.1 beats per minute
Standard Deviation 10.22
|
75.3 beats per minute
Standard Deviation 9.18
|
74.8 beats per minute
Standard Deviation 12.30
|
71.9 beats per minute
Standard Deviation 12.76
|
75.3 beats per minute
Standard Deviation 10.60
|
|
Heart Rate
Week 1
|
77.2 beats per minute
Standard Deviation 10.66
|
79.4 beats per minute
Standard Deviation 11.07
|
76.4 beats per minute
Standard Deviation 12.06
|
72.4 beats per minute
Standard Deviation 14.00
|
80.1 beats per minute
Standard Deviation 12.74
|
|
Heart Rate
Week 2
|
76.1 beats per minute
Standard Deviation 11.24
|
77.1 beats per minute
Standard Deviation 10.36
|
75.8 beats per minute
Standard Deviation 10.92
|
74.0 beats per minute
Standard Deviation 14.22
|
77.8 beats per minute
Standard Deviation 11.37
|
|
Heart Rate
Week 8 (1 hour pre-dose)
|
74.7 beats per minute
Standard Deviation 10.91
|
77.4 beats per minute
Standard Deviation 14.51
|
71.1 beats per minute
Standard Deviation 10.43
|
71.4 beats per minute
Standard Deviation 15.02
|
75.1 beats per minute
Standard Deviation 11.34
|
|
Heart Rate
Week 8 (1 hour post-dose)
|
73.9 beats per minute
Standard Deviation 9.59
|
77.3 beats per minute
Standard Deviation 12.66
|
72.3 beats per minute
Standard Deviation 10.92
|
69.2 beats per minute
Standard Deviation 15.58
|
71.3 beats per minute
Standard Deviation 11.29
|
|
Heart Rate
Week 16
|
75.6 beats per minute
Standard Deviation 9.84
|
75.0 beats per minute
Standard Deviation 11.54
|
75.9 beats per minute
Standard Deviation 11.95
|
70.9 beats per minute
Standard Deviation 15.77
|
75.6 beats per minute
Standard Deviation 13.60
|
|
Heart Rate
Week 24
|
77.5 beats per minute
Standard Deviation 10.44
|
79.9 beats per minute
Standard Deviation 11.68
|
75.3 beats per minute
Standard Deviation 11.22
|
72.7 beats per minute
Standard Deviation 13.81
|
77.3 beats per minute
Standard Deviation 9.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Respiratory Rate
Week 16
|
16.0 respirations per minute
Standard Deviation 2.00
|
16.9 respirations per minute
Standard Deviation 2.38
|
17.0 respirations per minute
Standard Deviation 2.24
|
16.2 respirations per minute
Standard Deviation 2.56
|
16.0 respirations per minute
Standard Deviation 1.67
|
|
Respiratory Rate
Week 24
|
16.1 respirations per minute
Standard Deviation 2.67
|
15.6 respirations per minute
Standard Deviation 2.38
|
15.1 respirations per minute
Standard Deviation 2.40
|
16.0 respirations per minute
Standard Deviation 2.64
|
15.8 respirations per minute
Standard Deviation 2.08
|
|
Respiratory Rate
Screening
|
16.2 respirations per minute
Standard Deviation 2.46
|
15.8 respirations per minute
Standard Deviation 2.89
|
16.3 respirations per minute
Standard Deviation 1.74
|
16.5 respirations per minute
Standard Deviation 2.83
|
16.1 respirations per minute
Standard Deviation 1.75
|
|
Respiratory Rate
Day 1 (1 hour pre-dose)
|
16.3 respirations per minute
Standard Deviation 2.62
|
16.2 respirations per minute
Standard Deviation 2.35
|
15.9 respirations per minute
Standard Deviation 2.14
|
16.2 respirations per minute
Standard Deviation 2.97
|
15.9 respirations per minute
Standard Deviation 1.83
|
|
Respiratory Rate
Day 1 (1 hour post-dose)
|
16.2 respirations per minute
Standard Deviation 2.64
|
16.3 respirations per minute
Standard Deviation 2.46
|
15.8 respirations per minute
Standard Deviation 2.42
|
16.2 respirations per minute
Standard Deviation 3.04
|
15.8 respirations per minute
Standard Deviation 1.98
|
|
Respiratory Rate
Week 1
|
16.3 respirations per minute
Standard Deviation 2.64
|
16.3 respirations per minute
Standard Deviation 2.33
|
16.1 respirations per minute
Standard Deviation 2.08
|
16.2 respirations per minute
Standard Deviation 2.99
|
15.7 respirations per minute
Standard Deviation 2.09
|
|
Respiratory Rate
Week 2
|
16.0 respirations per minute
Standard Deviation 2.49
|
16.4 respirations per minute
Standard Deviation 2.31
|
16.2 respirations per minute
Standard Deviation 2.29
|
16.8 respirations per minute
Standard Deviation 2.77
|
16.2 respirations per minute
Standard Deviation 1.94
|
|
Respiratory Rate
Week 8 (1 hour pre-dose)
|
15.8 respirations per minute
Standard Deviation 2.75
|
15.8 respirations per minute
Standard Deviation 2.19
|
16.3 respirations per minute
Standard Deviation 2.25
|
15.9 respirations per minute
Standard Deviation 3.02
|
16.1 respirations per minute
Standard Deviation 1.88
|
|
Respiratory Rate
Week 8 (1 hour post-dose)
|
16.2 respirations per minute
Standard Deviation 2.89
|
16.3 respirations per minute
Standard Deviation 2.18
|
16.6 respirations per minute
Standard Deviation 1.87
|
16.4 respirations per minute
Standard Deviation 3.00
|
16.0 respirations per minute
Standard Deviation 1.54
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening, Day 1, Week 2, 8, 16, 24Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Following parameters were analyzed for ECG: RR interval, PR interval, QRS complex, QT interval, QT interval corrected using the Fridericia formula (QTcF), and QT interval corrected using the Bazett's formula (QTcB).
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Screening: RR Interval
|
868.9 millisecond (msec)
Standard Deviation 152.10
|
863.3 millisecond (msec)
Standard Deviation 138.89
|
849.6 millisecond (msec)
Standard Deviation 136.23
|
878.5 millisecond (msec)
Standard Deviation 189.33
|
863.2 millisecond (msec)
Standard Deviation 143.31
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Screening: PR Interval
|
155.1 millisecond (msec)
Standard Deviation 22.47
|
154.3 millisecond (msec)
Standard Deviation 19.60
|
156.4 millisecond (msec)
Standard Deviation 20.83
|
154.8 millisecond (msec)
Standard Deviation 24.53
|
158.6 millisecond (msec)
Standard Deviation 28.85
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Screening: QRS Complex
|
90.2 millisecond (msec)
Standard Deviation 7.23
|
89.0 millisecond (msec)
Standard Deviation 11.62
|
88.6 millisecond (msec)
Standard Deviation 8.33
|
87.5 millisecond (msec)
Standard Deviation 9.17
|
90.6 millisecond (msec)
Standard Deviation 6.82
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Screening: QT Interval
|
389.1 millisecond (msec)
Standard Deviation 26.58
|
386.0 millisecond (msec)
Standard Deviation 28.24
|
389.1 millisecond (msec)
Standard Deviation 27.69
|
390.5 millisecond (msec)
Standard Deviation 37.31
|
384.0 millisecond (msec)
Standard Deviation 29.36
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Screening: QTcB Interval
|
420.2 millisecond (msec)
Standard Deviation 24.73
|
418.0 millisecond (msec)
Standard Deviation 20.17
|
424.2 millisecond (msec)
Standard Deviation 22.27
|
416.8 millisecond (msec)
Standard Deviation 22.81
|
415.3 millisecond (msec)
Standard Deviation 19.71
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Screening: QTcF Interval
|
409.3 millisecond (msec)
Standard Deviation 19.44
|
406.8 millisecond (msec)
Standard Deviation 18.29
|
411.9 millisecond (msec)
Standard Deviation 19.10
|
407.3 millisecond (msec)
Standard Deviation 21.13
|
404.3 millisecond (msec)
Standard Deviation 17.83
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Day 1: RR Interval
|
852.3 millisecond (msec)
Standard Deviation 149.92
|
848.7 millisecond (msec)
Standard Deviation 137.85
|
849.4 millisecond (msec)
Standard Deviation 126.73
|
883.4 millisecond (msec)
Standard Deviation 183.93
|
836.4 millisecond (msec)
Standard Deviation 117.33
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Day 1: PR Interval
|
153.9 millisecond (msec)
Standard Deviation 20.71
|
156.1 millisecond (msec)
Standard Deviation 17.76
|
153.6 millisecond (msec)
Standard Deviation 22.14
|
153.2 millisecond (msec)
Standard Deviation 23.98
|
158.2 millisecond (msec)
Standard Deviation 34.39
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Day 1: QRS Complex
|
87.6 millisecond (msec)
Standard Deviation 8.43
|
90.2 millisecond (msec)
Standard Deviation 9.91
|
87.3 millisecond (msec)
Standard Deviation 8.34
|
87.4 millisecond (msec)
Standard Deviation 10.46
|
89.1 millisecond (msec)
Standard Deviation 8.13
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Day 1: QT Interval
|
391.4 millisecond (msec)
Standard Deviation 31.92
|
382.1 millisecond (msec)
Standard Deviation 33.15
|
386.2 millisecond (msec)
Standard Deviation 27.28
|
392.5 millisecond (msec)
Standard Deviation 33.74
|
382.8 millisecond (msec)
Standard Deviation 23.82
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Day 1: QTcB Interval
|
425.6 millisecond (msec)
Standard Deviation 21.20
|
416.9 millisecond (msec)
Standard Deviation 18.02
|
420.8 millisecond (msec)
Standard Deviation 20.52
|
418.9 millisecond (msec)
Standard Deviation 18.21
|
418.4 millisecond (msec)
Standard Deviation 17.21
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Day 1: QTcF Interval
|
413.6 millisecond (msec)
Standard Deviation 19.16
|
404.8 millisecond (msec)
Standard Deviation 19.19
|
408.7 millisecond (msec)
Standard Deviation 18.27
|
409.5 millisecond (msec)
Standard Deviation 15.95
|
406.0 millisecond (msec)
Standard Deviation 15.28
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 2: RR Interval
|
835.3 millisecond (msec)
Standard Deviation 140.48
|
825.1 millisecond (msec)
Standard Deviation 117.52
|
857.5 millisecond (msec)
Standard Deviation 123.18
|
867.4 millisecond (msec)
Standard Deviation 191.34
|
833.4 millisecond (msec)
Standard Deviation 134.21
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 2: PR Interval
|
151.1 millisecond (msec)
Standard Deviation 21.46
|
158.4 millisecond (msec)
Standard Deviation 20.83
|
158.9 millisecond (msec)
Standard Deviation 21.31
|
152.7 millisecond (msec)
Standard Deviation 24.00
|
160.8 millisecond (msec)
Standard Deviation 28.15
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 2: QRS Complex
|
88.5 millisecond (msec)
Standard Deviation 8.81
|
89.6 millisecond (msec)
Standard Deviation 12.50
|
89.6 millisecond (msec)
Standard Deviation 9.51
|
88.5 millisecond (msec)
Standard Deviation 8.50
|
90.0 millisecond (msec)
Standard Deviation 7.07
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 2: QT Interval
|
382.6 millisecond (msec)
Standard Deviation 27.92
|
382.6 millisecond (msec)
Standard Deviation 30.00
|
389.5 millisecond (msec)
Standard Deviation 29.46
|
386.4 millisecond (msec)
Standard Deviation 36.77
|
382.0 millisecond (msec)
Standard Deviation 23.45
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 2: QTcB Interval
|
422.6 millisecond (msec)
Standard Deviation 23.99
|
423.1 millisecond (msec)
Standard Deviation 21.21
|
422.1 millisecond (msec)
Standard Deviation 17.73
|
418.1 millisecond (msec)
Standard Deviation 20.29
|
420.9 millisecond (msec)
Standard Deviation 20.48
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 2: QTcF Interval
|
408.6 millisecond (msec)
Standard Deviation 19.88
|
408.9 millisecond (msec)
Standard Deviation 20.89
|
410.6 millisecond (msec)
Standard Deviation 17.61
|
406.7 millisecond (msec)
Standard Deviation 18.85
|
407.3 millisecond (msec)
Standard Deviation 15.44
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 8: RR Interval
|
849.6 millisecond (msec)
Standard Deviation 134.00
|
842.7 millisecond (msec)
Standard Deviation 121.90
|
855.0 millisecond (msec)
Standard Deviation 126.13
|
919.6 millisecond (msec)
Standard Deviation 199.85
|
882.8 millisecond (msec)
Standard Deviation 152.53
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 8: PR Interval
|
153.4 millisecond (msec)
Standard Deviation 20.12
|
158.6 millisecond (msec)
Standard Deviation 19.44
|
157.0 millisecond (msec)
Standard Deviation 22.20
|
154.3 millisecond (msec)
Standard Deviation 25.04
|
156.8 millisecond (msec)
Standard Deviation 29.74
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 8: QRS Complex
|
87.4 millisecond (msec)
Standard Deviation 9.88
|
88.1 millisecond (msec)
Standard Deviation 11.59
|
89.4 millisecond (msec)
Standard Deviation 9.69
|
88.7 millisecond (msec)
Standard Deviation 10.52
|
90.5 millisecond (msec)
Standard Deviation 7.80
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 8: QT Interval
|
385.8 millisecond (msec)
Standard Deviation 29.34
|
379.8 millisecond (msec)
Standard Deviation 30.21
|
387.3 millisecond (msec)
Standard Deviation 21.80
|
401.5 millisecond (msec)
Standard Deviation 40.44
|
392.0 millisecond (msec)
Standard Deviation 28.49
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 8: QTcB Interval
|
419.8 millisecond (msec)
Standard Deviation 21.38
|
414.7 millisecond (msec)
Standard Deviation 16.98
|
421.1 millisecond (msec)
Standard Deviation 24.04
|
419.3 millisecond (msec)
Standard Deviation 16.86
|
419.8 millisecond (msec)
Standard Deviation 20.18
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 8: QTcF Interval
|
407.8 millisecond (msec)
Standard Deviation 19.36
|
402.5 millisecond (msec)
Standard Deviation 18.11
|
409.2 millisecond (msec)
Standard Deviation 18.95
|
412.8 millisecond (msec)
Standard Deviation 18.30
|
410.0 millisecond (msec)
Standard Deviation 16.65
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 16: RR Interval
|
825.7 millisecond (msec)
Standard Deviation 109.43
|
847.5 millisecond (msec)
Standard Deviation 138.15
|
799.6 millisecond (msec)
Standard Deviation 87.02
|
925.9 millisecond (msec)
Standard Deviation 224.34
|
865.4 millisecond (msec)
Standard Deviation 188.59
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 16: PR Interval
|
152.1 millisecond (msec)
Standard Deviation 24.39
|
157.1 millisecond (msec)
Standard Deviation 17.66
|
155.2 millisecond (msec)
Standard Deviation 18.75
|
156.6 millisecond (msec)
Standard Deviation 26.49
|
150.5 millisecond (msec)
Standard Deviation 21.33
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 16: QRS Complex
|
90.1 millisecond (msec)
Standard Deviation 7.69
|
89.3 millisecond (msec)
Standard Deviation 8.68
|
90.8 millisecond (msec)
Standard Deviation 8.85
|
89.2 millisecond (msec)
Standard Deviation 8.79
|
90.4 millisecond (msec)
Standard Deviation 6.33
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 16: QT Interval
|
386.6 millisecond (msec)
Standard Deviation 25.90
|
380.7 millisecond (msec)
Standard Deviation 35.74
|
381.3 millisecond (msec)
Standard Deviation 23.89
|
403.9 millisecond (msec)
Standard Deviation 37.73
|
385.8 millisecond (msec)
Standard Deviation 30.81
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 16: QTcB Interval
|
426.8 millisecond (msec)
Standard Deviation 20.63
|
418.0 millisecond (msec)
Standard Deviation 14.16
|
427.6 millisecond (msec)
Standard Deviation 25.18
|
421.6 millisecond (msec)
Standard Deviation 21.94
|
418.7 millisecond (msec)
Standard Deviation 24.51
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 16: QTcF Interval
|
412.8 millisecond (msec)
Standard Deviation 18.96
|
404.8 millisecond (msec)
Standard Deviation 17.65
|
411.4 millisecond (msec)
Standard Deviation 22.01
|
414.9 millisecond (msec)
Standard Deviation 17.40
|
406.9 millisecond (msec)
Standard Deviation 17.80
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 24: RR Interval
|
849.1 millisecond (msec)
Standard Deviation 116.70
|
850.6 millisecond (msec)
Standard Deviation 136.92
|
821.8 millisecond (msec)
Standard Deviation 122.24
|
894.9 millisecond (msec)
Standard Deviation 164.80
|
851.2 millisecond (msec)
Standard Deviation 106.90
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 24: PR Interval
|
155.4 millisecond (msec)
Standard Deviation 20.29
|
157.0 millisecond (msec)
Standard Deviation 17.56
|
157.7 millisecond (msec)
Standard Deviation 21.18
|
158.9 millisecond (msec)
Standard Deviation 23.25
|
159.1 millisecond (msec)
Standard Deviation 27.92
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 24: QRS Complex
|
89.2 millisecond (msec)
Standard Deviation 7.68
|
87.2 millisecond (msec)
Standard Deviation 11.48
|
89.4 millisecond (msec)
Standard Deviation 8.10
|
88.9 millisecond (msec)
Standard Deviation 8.56
|
89.4 millisecond (msec)
Standard Deviation 7.77
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 24: QT Interval
|
384.7 millisecond (msec)
Standard Deviation 28.57
|
386.4 millisecond (msec)
Standard Deviation 34.67
|
388.3 millisecond (msec)
Standard Deviation 27.18
|
395.0 millisecond (msec)
Standard Deviation 33.83
|
383.5 millisecond (msec)
Standard Deviation 24.31
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 24: QTcB Interval
|
418.7 millisecond (msec)
Standard Deviation 19.71
|
418.7 millisecond (msec)
Standard Deviation 19.47
|
427.7 millisecond (msec)
Standard Deviation 21.73
|
419.5 millisecond (msec)
Standard Deviation 23.12
|
418.4 millisecond (msec)
Standard Deviation 19.80
|
|
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Week 24: QTcF Interval
|
406.8 millisecond (msec)
Standard Deviation 19.45
|
407.3 millisecond (msec)
Standard Deviation 21.52
|
413.9 millisecond (msec)
Standard Deviation 20.07
|
410.8 millisecond (msec)
Standard Deviation 20.48
|
406.3 millisecond (msec)
Standard Deviation 18.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening, Day 1, Week 2, 8, 16, 24Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Electrocardiogram Parameter: Heart Rate
Screening
|
71.1 beats per minute
Standard Deviation 12.18
|
71.2 beats per minute
Standard Deviation 10.77
|
72.4 beats per minute
Standard Deviation 11.49
|
71.3 beats per minute
Standard Deviation 14.47
|
71.4 beats per minute
Standard Deviation 12.42
|
|
Electrocardiogram Parameter: Heart Rate
Day 1
|
72.4 beats per minute
Standard Deviation 12.41
|
72.5 beats per minute
Standard Deviation 11.34
|
72.3 beats per minute
Standard Deviation 11.58
|
70.7 beats per minute
Standard Deviation 14.36
|
73.2 beats per minute
Standard Deviation 11.06
|
|
Electrocardiogram Parameter: Heart Rate
Week 2
|
73.9 beats per minute
Standard Deviation 12.46
|
74.1 beats per minute
Standard Deviation 10.38
|
71.5 beats per minute
Standard Deviation 10.94
|
72.0 beats per minute
Standard Deviation 13.98
|
73.8 beats per minute
Standard Deviation 11.68
|
|
Electrocardiogram Parameter: Heart Rate
Week 8
|
72.3 beats per minute
Standard Deviation 11.47
|
72.8 beats per minute
Standard Deviation 11.66
|
71.7 beats per minute
Standard Deviation 10.93
|
68.4 beats per minute
Standard Deviation 15.47
|
69.9 beats per minute
Standard Deviation 12.56
|
|
Electrocardiogram Parameter: Heart Rate
Week 16
|
73.8 beats per minute
Standard Deviation 9.77
|
72.9 beats per minute
Standard Deviation 12.76
|
75.9 beats per minute
Standard Deviation 8.69
|
68.3 beats per minute
Standard Deviation 15.39
|
72.2 beats per minute
Standard Deviation 14.41
|
|
Electrocardiogram Parameter: Heart Rate
Week 24
|
71.9 beats per minute
Standard Deviation 9.81
|
72.4 beats per minute
Standard Deviation 11.98
|
74.7 beats per minute
Standard Deviation 11.55
|
69.3 beats per minute
Standard Deviation 13.12
|
71.5 beats per minute
Standard Deviation 9.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening, Week 2, 8, 16, 24Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
PVR volume is an objective assessment of the amount of urine left in the bladder after normal urination and will monitor whether the active treatment is having an adverse effect on lower urinary tract voiding function. The PVR volume assessed using trans-abdominal ultrasound (e.g., bladder scanner) with the participant in a supine position immediately after voluntary urination.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=39 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Post-void Residual (PVR) Volume
Screening
|
27.1 milliliter
Standard Deviation 31.44
|
22.3 milliliter
Standard Deviation 33.29
|
24.8 milliliter
Standard Deviation 36.99
|
25.2 milliliter
Standard Deviation 27.10
|
24.5 milliliter
Standard Deviation 35.56
|
|
Post-void Residual (PVR) Volume
Week 2
|
20.9 milliliter
Standard Deviation 30.43
|
11.6 milliliter
Standard Deviation 17.16
|
20.1 milliliter
Standard Deviation 34.58
|
20.7 milliliter
Standard Deviation 28.03
|
25.8 milliliter
Standard Deviation 39.61
|
|
Post-void Residual (PVR) Volume
Week 8
|
19.2 milliliter
Standard Deviation 24.37
|
11.9 milliliter
Standard Deviation 21.47
|
17.7 milliliter
Standard Deviation 21.36
|
21.4 milliliter
Standard Deviation 32.82
|
21.2 milliliter
Standard Deviation 29.39
|
|
Post-void Residual (PVR) Volume
Week 16
|
20.5 milliliter
Standard Deviation 37.61
|
10.9 milliliter
Standard Deviation 15.33
|
27.3 milliliter
Standard Deviation 47.43
|
25.7 milliliter
Standard Deviation 26.40
|
23.9 milliliter
Standard Deviation 31.41
|
|
Post-void Residual (PVR) Volume
Week 24
|
17.2 milliliter
Standard Deviation 25.05
|
14.3 milliliter
Standard Deviation 24.27
|
18.6 milliliter
Standard Deviation 33.84
|
16.8 milliliter
Standard Deviation 25.50
|
17.6 milliliter
Standard Deviation 22.14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening up to Week 24Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Urine was tested for specific gravity, pH, protein, glucose, ketones, blood, bilirubin, nitrites, and leukocyte, esterase using a urine dipstick. Number of participants with a laboratory abnormality meeting specified criteria: specific gravity (\<1.003 and \>1.030), urine pH (\<4.5 and \>8), protein (\>=1 value in qualitative test), glucose (\>=1 value in qualitative test), ketones (\>=1 value in qualitative test), blood (\>=1 value in qualitative test), bilirubin (\>=1 value in qualitative test), nitrites (\>=1), and leukocyte esterase (\>=1) are reported.
Outcome measures
| Measure |
Placebo
n=40 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Participants With Urinalysis Abnormalities
Urine Blood
|
10 Participants
|
11 Participants
|
8 Participants
|
11 Participants
|
10 Participants
|
|
Number of Participants With Urinalysis Abnormalities
Urine Specific Gravity
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Urinalysis Abnormalities
Urine pH
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Abnormalities
Urine Glucose
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Abnormalities
Urine Ketones
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Urinalysis Abnormalities
Urine Protein
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Urinalysis Abnormalities
Urine Bilirubin
|
1 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Urinalysis Abnormalities
Urine Nitrite
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Abnormalities
Urine Leukocyte Esterase
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening up to Week 24Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Laboratory examination included hematology, liver function, renal function, lipids, electrolytes, clinical chemistry, and urinalysis. Reported results include abnormal laboratory findings without regard to baseline abnormality.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
28 Participants
|
21 Participants
|
24 Participants
|
24 Participants
|
25 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 112 days after the last dose (up to Week 24)Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 Participants
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
AEs
|
24 Participants
|
30 Participants
|
24 Participants
|
29 Participants
|
23 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 8, 16, 24Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). In this outcome measure number of participants with presence of anti-tanezumab antibodies are reported.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=33 Participants
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=35 Participants
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=36 Participants
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Number of Participants With Anti-Drug Antibody (ADA)
Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibody (ADA)
Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibody (ADA)
Week 16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibody (ADA)
Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Tanezumab 1 mg
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Tanezumab 2.5 mg
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Tanezumab 10 mg
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Tanezumab 20 mg
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=42 participants at risk
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 participants at risk
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 participants at risk
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 participants at risk
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 participants at risk
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
Other adverse events
| Measure |
Placebo
n=42 participants at risk
Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 1 mg
n=41 participants at risk
Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 2.5 mg
n=37 participants at risk
Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 10 mg
n=40 participants at risk
Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
Tanezumab 20 mg
n=40 participants at risk
Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
|
|---|---|---|---|---|---|
|
Eye disorders
Eye swelling
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.4%
2/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
9.8%
4/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
2/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
4.9%
2/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
9.8%
4/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
General disorders
Chest pain
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
4.9%
2/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
General disorders
Fatigue
|
2.4%
1/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
7.3%
3/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.4%
2/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
General disorders
Injection site reaction
|
9.5%
4/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
9.8%
4/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
General disorders
Malaise
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
4.9%
2/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
General disorders
Oedema peripheral
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
7.5%
3/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Infections and infestations
Bronchitis
|
2.4%
1/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Infections and infestations
Ear infection
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
2/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
4.9%
2/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
14.6%
6/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
7.5%
3/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
1/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
4.9%
2/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
4/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
7.3%
3/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.4%
2/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
15.0%
6/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
10.0%
4/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
9.8%
4/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
10.0%
4/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.4%
2/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
4.9%
2/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
7.5%
3/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.4%
1/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
4.9%
2/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
2/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
9.8%
4/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
7.5%
3/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.4%
1/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Nervous system disorders
Allodynia
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Nervous system disorders
Decreased vibratory sense
|
4.8%
2/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.4%
2/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
7.5%
3/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Nervous system disorders
Headache
|
9.5%
4/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
17.1%
7/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
8.1%
3/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
17.5%
7/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
10.0%
4/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
7.5%
3/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
2.4%
1/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
7.5%
3/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Nervous system disorders
Paraesthesia
|
7.1%
3/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
7.3%
3/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
22.5%
9/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
4.9%
2/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.4%
2/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.4%
2/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
10.0%
4/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Renal and urinary disorders
Cystitis interstitial
|
7.1%
3/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Renal and urinary disorders
Dysuria
|
4.8%
2/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.5%
1/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
7.3%
3/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.8%
2/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
2/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/42
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.4%
1/41
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
2.7%
1/37
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
5.0%
2/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
0.00%
0/40
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER