Trial Outcomes & Findings for Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study (NCT NCT01089725)

Results Overview

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

385 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2021-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Overall Study STARTED	72	75	65	87	86
Overall Study Treated	72	74	63	86	84
Overall Study COMPLETED	6	7	4	8	6
Overall Study NOT COMPLETED	66	68	61	79	80

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Overall Study Adverse Event	1	1	0	0	2
Overall Study Lack of Efficacy	4	3	1	0	4
Overall Study Lost to Follow-up	2	2	0	3	0
Overall Study Protocol Violation	0	0	1	1	0
Overall Study Withdrawal by Subject	5	5	4	5	4
Overall Study Study Terminated by Sponsor	51	56	53	68	68
Overall Study Randomized, but not treated	0	1	2	1	2
Overall Study Other	3	0	0	1	0

Baseline Characteristics

Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.	Total n=379 Participants Total of all reporting groups
Age, Customized 18 to 44 years	8 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants	4 Participants n=483 Participants	3 Participants n=36 Participants	25 Participants n=10 Participants
Age, Customized 45 to 64 years	38 Participants n=93 Participants	48 Participants n=4 Participants	32 Participants n=27 Participants	62 Participants n=483 Participants	56 Participants n=36 Participants	236 Participants n=10 Participants
Age, Customized Greater than or equal to (>=) 65 years	26 Participants n=93 Participants	23 Participants n=4 Participants	24 Participants n=27 Participants	20 Participants n=483 Participants	25 Participants n=36 Participants	118 Participants n=10 Participants
Sex: Female, Male Female	47 Participants n=93 Participants	48 Participants n=4 Participants	36 Participants n=27 Participants	54 Participants n=483 Participants	48 Participants n=36 Participants	233 Participants n=10 Participants
Sex: Female, Male Male	25 Participants n=93 Participants	26 Participants n=4 Participants	27 Participants n=27 Participants	32 Participants n=483 Participants	36 Participants n=36 Participants	146 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). Last observation carried forward (LOCF) method was used to impute missing values.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 Baseline	7.31 units on a scale Standard Deviation 1.41	7.70 units on a scale Standard Deviation 1.46	7.48 units on a scale Standard Deviation 1.43	7.51 units on a scale Standard Deviation 1.29	7.24 units on a scale Standard Deviation 1.37
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 Change at Week 16	-2.79 units on a scale Standard Deviation 2.14	-3.84 units on a scale Standard Deviation 2.79	-3.77 units on a scale Standard Deviation 2.62	-3.88 units on a scale Standard Deviation 2.72	-3.63 units on a scale Standard Deviation 2.41

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint in the past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=83 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 Baseline	6.99 units on a scale Standard Deviation 1.67	7.25 units on a scale Standard Deviation 1.60	7.03 units on a scale Standard Deviation 1.64	7.12 units on a scale Standard Deviation 1.42	6.75 units on a scale Standard Deviation 1.42
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 Change at Week 16	-2.29 units on a scale Standard Deviation 2.02	-3.28 units on a scale Standard Deviation 2.89	-3.22 units on a scale Standard Deviation 2.49	-3.51 units on a scale Standard Deviation 2.57	-3.18 units on a scale Standard Deviation 2.28

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participants answered the question: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities) and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=83 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 Change at Week 16	-0.81 units on a scale Standard Deviation 0.87	-1.03 units on a scale Standard Deviation 1.02	-0.92 units on a scale Standard Deviation 0.92	-1.08 units on a scale Standard Deviation 1.10	-0.92 units on a scale Standard Deviation 0.97
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 Baseline	3.47 units on a scale Standard Deviation 0.63	3.43 units on a scale Standard Deviation 0.64	3.43 units on a scale Standard Deviation 0.61	3.49 units on a scale Standard Deviation 0.65	3.30 units on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, and 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 Change at Week 2	-2.46 units on a scale Standard Deviation 2.28	-3.76 units on a scale Standard Deviation 2.69	-3.23 units on a scale Standard Deviation 2.70	-3.19 units on a scale Standard Deviation 2.67	-2.59 units on a scale Standard Deviation 2.64
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 Change at Week 8	-2.74 units on a scale Standard Deviation 2.09	-3.89 units on a scale Standard Deviation 2.76	-3.80 units on a scale Standard Deviation 2.64	-3.89 units on a scale Standard Deviation 2.73	-3.59 units on a scale Standard Deviation 2.38
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 Change at Week 12	-2.81 units on a scale Standard Deviation 2.13	-3.87 units on a scale Standard Deviation 2.76	-3.81 units on a scale Standard Deviation 2.67	-3.88 units on a scale Standard Deviation 2.72	-3.62 units on a scale Standard Deviation 2.42
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 Change at Week 1	-2.15 units on a scale Standard Deviation 2.25	-3.06 units on a scale Standard Deviation 2.47	-2.67 units on a scale Standard Deviation 2.56	-3.27 units on a scale Standard Deviation 2.49	-3.41 units on a scale Standard Deviation 2.76
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 Change at Week 4	-2.74 units on a scale Standard Deviation 2.20	-4.15 units on a scale Standard Deviation 2.72	-3.63 units on a scale Standard Deviation 2.59	-3.89 units on a scale Standard Deviation 2.83	-3.58 units on a scale Standard Deviation 2.47

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, and 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those who were evaluable for this measure.

The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint in the past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=83 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 Change at Week 4	-2.21 units on a scale Standard Deviation 2.07	-3.55 units on a scale Standard Deviation 2.81	-3.20 units on a scale Standard Deviation 2.52	-3.57 units on a scale Standard Deviation 2.53	-3.17 units on a scale Standard Deviation 2.31
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 Change at Week 8	-2.26 units on a scale Standard Deviation 2.01	-3.31 units on a scale Standard Deviation 2.86	-3.28 units on a scale Standard Deviation 2.53	-3.51 units on a scale Standard Deviation 2.58	-3.13 units on a scale Standard Deviation 2.25
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 Change at Week 12	-2.31 units on a scale Standard Deviation 2.02	-3.29 units on a scale Standard Deviation 2.87	-3.27 units on a scale Standard Deviation 2.55	-3.50 units on a scale Standard Deviation 2.58	-3.16 units on a scale Standard Deviation 2.29
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 Change at Week 2	-1.97 units on a scale Standard Deviation 2.08	-3.27 units on a scale Standard Deviation 2.73	-2.89 units on a scale Standard Deviation 2.57	-3.01 units on a scale Standard Deviation 2.46	-2.45 units on a scale Standard Deviation 2.36
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 Change at Week 1	-1.75 units on a scale Standard Deviation 2.24	-2.78 units on a scale Standard Deviation 2.49	-2.22 units on a scale Standard Deviation 2.26	-2.99 units on a scale Standard Deviation 2.30	-2.99 units on a scale Standard Deviation 2.46

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, and 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participants answered the question: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities) and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=83 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 Change at Week 1	-0.57 units on a scale Standard Deviation 0.82	-0.82 units on a scale Standard Deviation 0.94	-0.75 units on a scale Standard Deviation 0.86	-0.87 units on a scale Standard Deviation 0.85	-0.88 units on a scale Standard Deviation 1.04
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 Change at Week 2	-0.67 units on a scale Standard Deviation 0.86	-0.93 units on a scale Standard Deviation 1.05	-0.83 units on a scale Standard Deviation 0.89	-0.94 units on a scale Standard Deviation 1.01	-0.58 units on a scale Standard Deviation 0.93
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 Change at Week 4	-0.76 units on a scale Standard Deviation 0.76	-1.12 units on a scale Standard Deviation 1.03	-1.02 units on a scale Standard Deviation 0.92	-1.03 units on a scale Standard Deviation 1.10	-0.88 units on a scale Standard Deviation 0.90
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 Change at Week 8	-0.78 units on a scale Standard Deviation 0.83	-1.07 units on a scale Standard Deviation 1.00	0.95 units on a scale Standard Deviation 0.92	-1.08 units on a scale Standard Deviation 1.10	-0.90 units on a scale Standard Deviation 0.96
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 Change at Week 12	-0.81 units on a scale Standard Deviation 0.87	-1.05 units on a scale Standard Deviation 0.99	-0.94 units on a scale Standard Deviation 0.93	-1.08 units on a scale Standard Deviation 1.10	-0.92 units on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

The OMERACT-OARSI responder index is based on 3 parameters. OMERACT-OARSI response: greater than or equal to (\>=) 50 percent (%) improvement from baseline and absolute change from baseline of \>=2 units at week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit at week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score range: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score range: 0-10, higher score=higher pain/difficulty).

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Week 1	41.7 percentage of participants	68.9 percentage of participants	58.7 percentage of participants	68.6 percentage of participants	64.3 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Week 2	54.2 percentage of participants	68.9 percentage of participants	68.3 percentage of participants	64.0 percentage of participants	59.5 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Week 4	63.9 percentage of participants	78.4 percentage of participants	74.6 percentage of participants	72.1 percentage of participants	73.8 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Week 8	59.7 percentage of participants	74.3 percentage of participants	74.6 percentage of participants	79.1 percentage of participants	76.2 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Week 12	61.1 percentage of participants	74.3 percentage of participants	74.6 percentage of participants	79.1 percentage of participants	76.2 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Week 16	61.1 percentage of participants	74.3 percentage of participants	74.6 percentage of participants	79.1 percentage of participants	76.2 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 12: >=70% reduction	18.1 percentage of participants	40.5 percentage of participants	42.9 percentage of participants	38.4 percentage of participants	31.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 12: >=90% reduction	4.2 percentage of participants	24.3 percentage of participants	19.0 percentage of participants	14.0 percentage of participants	17.9 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 4: >=90% reduction	5.6 percentage of participants	27.0 percentage of participants	19.0 percentage of participants	16.3 percentage of participants	13.1 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 8: >=30% reduction	59.7 percentage of participants	62.2 percentage of participants	68.3 percentage of participants	69.8 percentage of participants	71.4 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 1: >=30% reduction	36.1 percentage of participants	54.1 percentage of participants	49.2 percentage of participants	65.1 percentage of participants	64.3 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 1: >=50% reduction	25.0 percentage of participants	40.5 percentage of participants	33.3 percentage of participants	45.3 percentage of participants	51.2 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 1: >=70% reduction	13.9 percentage of participants	23.0 percentage of participants	23.8 percentage of participants	27.9 percentage of participants	33.3 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 1: >=90% reduction	8.3 percentage of participants	9.5 percentage of participants	11.1 percentage of participants	5.8 percentage of participants	14.3 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 2: >=30% reduction	48.6 percentage of participants	63.5 percentage of participants	57.1 percentage of participants	61.6 percentage of participants	54.8 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 2: >=50% reduction	30.6 percentage of participants	52.7 percentage of participants	44.4 percentage of participants	38.4 percentage of participants	39.3 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 2: >=70% reduction	18.1 percentage of participants	36.5 percentage of participants	30.2 percentage of participants	27.9 percentage of participants	20.2 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 2: >=90% reduction	8.3 percentage of participants	17.6 percentage of participants	15.9 percentage of participants	14.0 percentage of participants	6.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 4: >=30% reduction	56.9 percentage of participants	66.2 percentage of participants	65.1 percentage of participants	66.3 percentage of participants	66.7 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 4: >=50% reduction	31.9 percentage of participants	55.4 percentage of participants	54.0 percentage of participants	53.5 percentage of participants	53.6 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 4: >=70% reduction	19.4 percentage of participants	44.6 percentage of participants	34.9 percentage of participants	43.0 percentage of participants	32.1 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 8: >=50% reduction	33.3 percentage of participants	47.3 percentage of participants	57.1 percentage of participants	53.5 percentage of participants	51.2 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 8: >=70% reduction	16.7 percentage of participants	40.5 percentage of participants	42.9 percentage of participants	38.4 percentage of participants	29.8 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 8: >=90% reduction	4.2 percentage of participants	24.3 percentage of participants	19.0 percentage of participants	15.1 percentage of participants	16.7 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 12: >=30% reduction	61.1 percentage of participants	62.2 percentage of participants	68.3 percentage of participants	69.8 percentage of participants	70.2 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 12: >=50% reduction	34.7 percentage of participants	45.9 percentage of participants	57.1 percentage of participants	53.5 percentage of participants	51.2 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 16: >=30% reduction	61.1 percentage of participants	60.8 percentage of participants	68.3 percentage of participants	69.8 percentage of participants	70.2 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 16: >=50% reduction	33.3 percentage of participants	45.9 percentage of participants	57.1 percentage of participants	53.5 percentage of participants	52.4 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 16: >=70% reduction	18.1 percentage of participants	40.5 percentage of participants	41.3 percentage of participants	38.4 percentage of participants	31.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 16: >=90% reduction	4.2 percentage of participants	24.3 percentage of participants	17.5 percentage of participants	14.0 percentage of participants	17.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 16

Population: ITT population. LOCF method was used to impute missing values. Results for Week 1, 2, 4, 8 and 12 were not reported because analysis was not performed as per change in planned analysis.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 are reported.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Week 16: >=70% reduction	13 Participants	30 Participants	26 Participants	33 Participants	26 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Week 16: >=80% reduction	11 Participants	24 Participants	17 Participants	22 Participants	21 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Week 16: 100% reduction	1 Participants	8 Participants	3 Participants	5 Participants	8 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Week 16: Greater than 0% reduction	63 Participants	69 Participants	57 Participants	77 Participants	78 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Week 16: >=10% reduction	57 Participants	64 Participants	53 Participants	72 Participants	73 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Week 16: >=20% reduction	50 Participants	56 Participants	47 Participants	65 Participants	65 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Week 16: >=30% reduction	44 Participants	45 Participants	43 Participants	60 Participants	59 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Week 16: >=40% reduction	32 Participants	40 Participants	39 Participants	54 Participants	52 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Week 16: >=50% reduction	24 Participants	34 Participants	36 Participants	46 Participants	44 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Week 16: >=60% reduction	21 Participants	30 Participants	29 Participants	42 Participants	34 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Week 16: >=90% reduction	3 Participants	18 Participants	11 Participants	12 Participants	15 Participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Participants answered the question: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities) and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis Week 2	10 Participants	23 Participants	15 Participants	23 Participants	10 Participants
Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis Week 4	9 Participants	24 Participants	20 Participants	25 Participants	18 Participants
Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis Week 1	11 Participants	17 Participants	12 Participants	21 Participants	24 Participants
Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis Week 8	13 Participants	22 Participants	16 Participants	27 Participants	23 Participants
Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis Week 12	14 Participants	21 Participants	16 Participants	27 Participants	24 Participants
Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis Week 16	14 Participants	21 Participants	15 Participants	27 Participants	24 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' included those participants who were evaluable for this measure.

Participants assessed average osteoarthritis pain in their knee in the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Higher score indicated greater pain. Baseline score was calculated as the mean of the scores over the 3 days in the initial pain assessment period and a weekly mean was calculated using the daily pain scores within each study week.

Outcome measures

Outcome measures
Measure	Placebo n=70 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=62 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=85 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 Change at Week 2	-1.74 units on a scale Standard Deviation 2.27	-2.54 units on a scale Standard Deviation 2.25	-2.23 units on a scale Standard Deviation 2.33	-2.47 units on a scale Standard Deviation 2.62	-1.78 units on a scale Standard Deviation 2.17
Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 Change at Week 16	-2.33 units on a scale Standard Deviation 2.59	-2.49 units on a scale Standard Deviation 2.45	-2.93 units on a scale Standard Deviation 2.39	-2.97 units on a scale Standard Deviation 2.65	-2.33 units on a scale Standard Deviation 2.29
Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 Baseline	7.12 units on a scale Standard Deviation 1.75	6.96 units on a scale Standard Deviation 1.97	6.72 units on a scale Standard Deviation 2.10	6.93 units on a scale Standard Deviation 1.76	6.44 units on a scale Standard Deviation 1.88
Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 Change at Week 1	-1.17 units on a scale Standard Deviation 1.93	-1.36 units on a scale Standard Deviation 1.69	-1.27 units on a scale Standard Deviation 1.73	-1.93 units on a scale Standard Deviation 1.99	-1.82 units on a scale Standard Deviation 1.96
Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 Change at Week 4	-2.10 units on a scale Standard Deviation 2.30	-2.85 units on a scale Standard Deviation 2.35	-2.95 units on a scale Standard Deviation 2.41	-3.12 units on a scale Standard Deviation 2.73	-2.37 units on a scale Standard Deviation 2.25
Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 Change at Week 8	-2.27 units on a scale Standard Deviation 2.60	-2.55 units on a scale Standard Deviation 2.47	-2.85 units on a scale Standard Deviation 2.26	-3.01 units on a scale Standard Deviation 2.63	-2.34 units on a scale Standard Deviation 2.34
Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 Change at Week 12	-2.32 units on a scale Standard Deviation 2.59	-2.48 units on a scale Standard Deviation 2.44	-3.00 units on a scale Standard Deviation 2.43	-3.00 units on a scale Standard Deviation 2.68	-2.34 units on a scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced in the index joint in the past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10, with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in movement of the knee.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Baseline	7.19 units on a scale Standard Deviation 1.78	7.33 units on a scale Standard Deviation 2.20	7.26 units on a scale Standard Deviation 1.73	7.41 units on a scale Standard Deviation 1.59	6.99 units on a scale Standard Deviation 1.85
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 1	-1.75 units on a scale Standard Deviation 1.92	-2.78 units on a scale Standard Deviation 2.65	-2.40 units on a scale Standard Deviation 2.44	-3.18 units on a scale Standard Deviation 2.65	-3.24 units on a scale Standard Deviation 2.70
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 2	-2.05 units on a scale Standard Deviation 2.11	-3.38 units on a scale Standard Deviation 2.81	-3.10 units on a scale Standard Deviation 2.71	-3.38 units on a scale Standard Deviation 2.74	-2.64 units on a scale Standard Deviation 2.61
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 4	-2.17 units on a scale Standard Deviation 2.19	-3.61 units on a scale Standard Deviation 3.05	-3.52 units on a scale Standard Deviation 2.70	-3.85 units on a scale Standard Deviation 2.82	-3.38 units on a scale Standard Deviation 2.72
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 8	-2.15 units on a scale Standard Deviation 2.04	-3.32 units on a scale Standard Deviation 3.18	-3.52 units on a scale Standard Deviation 2.68	-3.87 units on a scale Standard Deviation 2.89	-3.32 units on a scale Standard Deviation 2.66
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 12	-2.19 units on a scale Standard Deviation 2.03	-3.30 units on a scale Standard Deviation 3.19	-3.52 units on a scale Standard Deviation 2.69	-3.86 units on a scale Standard Deviation 2.87	-3.36 units on a scale Standard Deviation 2.71
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 16	-2.17 units on a scale Standard Deviation 2.03	-3.30 units on a scale Standard Deviation 3.20	-3.47 units on a scale Standard Deviation 2.64	-3.87 units on a scale Standard Deviation 2.87	-3.37 units on a scale Standard Deviation 2.69

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

WOMAC: self-administered, disease-specific 24-item questionnaire, which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores. WOMAC pain, physical function and stiffness subscale and average score ranges from 0 to 10, where higher score indicates worse response.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 4	-2.39 units on a scale Standard Deviation 2.00	-3.78 units on a scale Standard Deviation 2.72	-3.46 units on a scale Standard Deviation 2.49	-3.77 units on a scale Standard Deviation 2.60	-3.37 units on a scale Standard Deviation 2.36
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 Baseline	7.17 units on a scale Standard Deviation 1.44	7.43 units on a scale Standard Deviation 1.58	7.26 units on a scale Standard Deviation 1.44	7.35 units on a scale Standard Deviation 1.27	6.99 units on a scale Standard Deviation 1.30
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 1	-1.88 units on a scale Standard Deviation 2.04	-2.89 units on a scale Standard Deviation 2.36	-2.43 units on a scale Standard Deviation 2.25	-3.15 units on a scale Standard Deviation 2.37	-3.21 units on a scale Standard Deviation 2.48
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 2	-2.18 units on a scale Standard Deviation 2.01	-3.48 units on a scale Standard Deviation 2.59	-3.07 units on a scale Standard Deviation 2.55	-3.19 units on a scale Standard Deviation 2.50	-2.56 units on a scale Standard Deviation 2.37
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 8	-2.40 units on a scale Standard Deviation 1.88	-3.52 units on a scale Standard Deviation 2.79	-3.54 units on a scale Standard Deviation 2.50	-3.76 units on a scale Standard Deviation 2.59	-3.34 units on a scale Standard Deviation 2.27
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 12	-2.45 units on a scale Standard Deviation 1.90	-3.50 units on a scale Standard Deviation 2.79	-3.54 units on a scale Standard Deviation 2.53	-3.75 units on a scale Standard Deviation 2.58	-3.38 units on a scale Standard Deviation 2.31
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 16	-2.44 units on a scale Standard Deviation 1.90	-3.49 units on a scale Standard Deviation 2.81	-3.49 units on a scale Standard Deviation 2.47	-3.75 units on a scale Standard Deviation 2.58	-3.39 units on a scale Standard Deviation 2.30

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 1, 2, 4, 8, 12, and 16 Baseline	7.28 units on a scale Standard Deviation 1.69	7.73 units on a scale Standard Deviation 1.74	7.43 units on a scale Standard Deviation 1.71	7.41 units on a scale Standard Deviation 1.58	7.24 units on a scale Standard Deviation 1.68
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 2	-2.40 units on a scale Standard Deviation 2.75	-3.82 units on a scale Standard Deviation 2.82	-3.29 units on a scale Standard Deviation 2.77	-3.26 units on a scale Standard Deviation 2.81	-2.75 units on a scale Standard Deviation 2.82
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 1	-2.01 units on a scale Standard Deviation 2.76	-3.14 units on a scale Standard Deviation 2.54	-2.67 units on a scale Standard Deviation 2.74	-3.30 units on a scale Standard Deviation 2.67	-3.40 units on a scale Standard Deviation 2.83
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 4	-2.68 units on a scale Standard Deviation 2.63	-4.20 units on a scale Standard Deviation 2.94	-3.60 units on a scale Standard Deviation 2.67	-3.91 units on a scale Standard Deviation 2.89	-3.64 units on a scale Standard Deviation 2.56
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 8	-2.51 units on a scale Standard Deviation 2.49	-4.01 units on a scale Standard Deviation 2.94	-3.84 units on a scale Standard Deviation 2.71	-3.85 units on a scale Standard Deviation 2.85	-3.62 units on a scale Standard Deviation 2.50
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 12	-2.57 units on a scale Standard Deviation 2.53	-3.99 units on a scale Standard Deviation 2.94	-3.84 units on a scale Standard Deviation 2.74	-3.84 units on a scale Standard Deviation 2.84	-3.64 units on a scale Standard Deviation 2.54
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 16	-2.56 units on a scale Standard Deviation 2.53	-3.99 units on a scale Standard Deviation 2.96	-3.83 units on a scale Standard Deviation 2.72	-3.85 units on a scale Standard Deviation 2.83	-3.65 units on a scale Standard Deviation 2.54

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 1, 2, 4, 8, 12, and 16 Baseline	8.50 units on a scale Standard Deviation 1.39	8.65 units on a scale Standard Deviation 1.34	8.44 units on a scale Standard Deviation 1.17	8.40 units on a scale Standard Deviation 1.33	8.25 units on a scale Standard Deviation 1.26
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 1	-2.21 units on a scale Standard Deviation 2.75	-3.14 units on a scale Standard Deviation 2.56	-2.71 units on a scale Standard Deviation 2.69	-3.30 units on a scale Standard Deviation 2.59	-3.45 units on a scale Standard Deviation 2.95
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 4	-2.92 units on a scale Standard Deviation 2.69	-4.36 units on a scale Standard Deviation 3.00	-3.76 units on a scale Standard Deviation 2.84	-4.08 units on a scale Standard Deviation 3.02	-3.89 units on a scale Standard Deviation 2.58
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 8	-2.85 units on a scale Standard Deviation 2.57	-4.03 units on a scale Standard Deviation 3.06	-3.98 units on a scale Standard Deviation 2.76	-3.98 units on a scale Standard Deviation 2.93	-3.86 units on a scale Standard Deviation 2.60
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 2	-2.74 units on a scale Standard Deviation 2.72	-3.93 units on a scale Standard Deviation 2.93	-3.54 units on a scale Standard Deviation 2.82	-3.50 units on a scale Standard Deviation 2.99	-2.95 units on a scale Standard Deviation 2.83
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 12	-2.93 units on a scale Standard Deviation 2.61	-4.00 units on a scale Standard Deviation 3.04	-3.98 units on a scale Standard Deviation 2.78	-3.98 units on a scale Standard Deviation 2.94	-3.89 units on a scale Standard Deviation 2.64
Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 1, 2, 4, 8, 12, and 16 Change at Week 16	-2.92 units on a scale Standard Deviation 2.60	-3.96 units on a scale Standard Deviation 3.08	-3.94 units on a scale Standard Deviation 2.73	-3.99 units on a scale Standard Deviation 2.94	-3.92 units on a scale Standard Deviation 2.62

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

SF-36v2 is a standardized self-administered survey evaluating 8 aspects/domains of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The total score for each domain is scaled 0-100 (100 = highest level of functioning).

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=73 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=62 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Change at Week 16: Mental Health Score	0.00 units on a scale Standard Deviation 0.00	0.14 units on a scale Standard Deviation 1.17	-0.56 units on a scale Standard Deviation 4.45	0.23 units on a scale Standard Deviation 2.16	-0.18 units on a scale Standard Deviation 1.64
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Baseline: General Health Score	66.01 units on a scale Standard Deviation 18.38	66.81 units on a scale Standard Deviation 20.54	68.73 units on a scale Standard Deviation 17.95	65.72 units on a scale Standard Deviation 19.98	65.02 units on a scale Standard Deviation 19.42
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Baseline: Physical Function Score	34.30 units on a scale Standard Deviation 23.80	32.05 units on a scale Standard Deviation 20.80	30.63 units on a scale Standard Deviation 18.07	38.55 units on a scale Standard Deviation 23.58	37.35 units on a scale Standard Deviation 21.80
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Baseline: Role Physical Score	40.85 units on a scale Standard Deviation 27.57	42.64 units on a scale Standard Deviation 27.68	39.42 units on a scale Standard Deviation 23.07	47.31 units on a scale Standard Deviation 27.70	49.03 units on a scale Standard Deviation 27.03
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Baseline: Bodily Pain Score	34.18 units on a scale Standard Deviation 19.25	32.85 units on a scale Standard Deviation 16.97	34.10 units on a scale Standard Deviation 17.02	33.70 units on a scale Standard Deviation 19.80	36.31 units on a scale Standard Deviation 18.06
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Baseline: Vitality Score	50.62 units on a scale Standard Deviation 20.97	52.91 units on a scale Standard Deviation 21.98	55.04 units on a scale Standard Deviation 18.35	51.74 units on a scale Standard Deviation 20.49	50.45 units on a scale Standard Deviation 19.97
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Baseline: Social Function Score	64.96 units on a scale Standard Deviation 30.95	69.69 units on a scale Standard Deviation 26.59	72.18 units on a scale Standard Deviation 24.94	65.41 units on a scale Standard Deviation 28.42	69.79 units on a scale Standard Deviation 25.61
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Baseline: Role Emotional Score	67.72 units on a scale Standard Deviation 31.81	73.63 units on a scale Standard Deviation 32.36	73.25 units on a scale Standard Deviation 29.99	73.45 units on a scale Standard Deviation 30.85	73.31 units on a scale Standard Deviation 28.22
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Baseline: Mental Health Score	72.89 units on a scale Standard Deviation 20.03	73.90 units on a scale Standard Deviation 19.10	77.82 units on a scale Standard Deviation 16.59	75.41 units on a scale Standard Deviation 17.41	75.77 units on a scale Standard Deviation 16.84
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Change at Week 16: General Health Score	0.07 units on a scale Standard Deviation 0.59	-0.48 units on a scale Standard Deviation 2.91	-0.08 units on a scale Standard Deviation 0.64	0.00 units on a scale Standard Deviation 0.00	0.44 units on a scale Standard Deviation 4.04
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Change at Week 16: Physical Function Score	0.35 units on a scale Standard Deviation 2.97	-0.21 units on a scale Standard Deviation 4.75	0.48 units on a scale Standard Deviation 3.81	0.35 units on a scale Standard Deviation 3.23	0.06 units on a scale Standard Deviation 0.55
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Change at Week 16: Role Physical Score	0.26 units on a scale Standard Deviation 2.23	-0.77 units on a scale Standard Deviation 9.99	0.20 units on a scale Standard Deviation 1.59	0.00 units on a scale Standard Deviation 0.00	0.22 units on a scale Standard Deviation 2.05
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Change at Week 16: Bodily Pain Score	0.30 units on a scale Standard Deviation 2.49	-0.29 units on a scale Standard Deviation 2.34	0.31 units on a scale Standard Deviation 2.41	0.00 units on a scale Standard Deviation 0.00	0.36 units on a scale Standard Deviation 3.27
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Change at Week 16: Vitality Score	0.18 units on a scale Standard Deviation 1.48	-0.43 units on a scale Standard Deviation 3.66	-0.40 units on a scale Standard Deviation 3.18	0.07 units on a scale Standard Deviation 0.67	0.22 units on a scale Standard Deviation 2.05
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Change at Week 16: Social Function Score	0.18 units on a scale Standard Deviation 1.48	-0.34 units on a scale Standard Deviation 2.93	0.60 units on a scale Standard Deviation 4.76	0.29 units on a scale Standard Deviation 2.70	0.30 units on a scale Standard Deviation 2.73
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 Change at Week 16: Role Emotional Score	0.00 units on a scale Standard Deviation 0.00	0.68 units on a scale Standard Deviation 5.85	0.13 units on a scale Standard Deviation 1.06	0.29 units on a scale Standard Deviation 2.70	0.10 units on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

SF-36v2: standardized self-administered survey evaluating 8 aspects of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each aspect were scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale=(observed score - mean score for general 1990 United States \[US\] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score \[better functioning\])/lower (in case of negative z-score \[worse functioning\]) participant's value was relative to the mean of the reference population.

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=73 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=62 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 Baseline: Physical Component Score	-1.78 z-score Standard Deviation 0.81	-1.86 z-score Standard Deviation 0.79	-1.93 z-score Standard Deviation 0.70	-1.71 z-score Standard Deviation 0.88	-1.68 z-score Standard Deviation 0.82
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 Baseline: Mental Component Score	0.03 z-score Standard Deviation 1.25	0.27 z-score Standard Deviation 1.23	0.44 z-score Standard Deviation 1.11	0.16 z-score Standard Deviation 1.17	0.19 z-score Standard Deviation 1.08
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 Change at Week 16: Physical Component Score	0.01 z-score Standard Deviation 0.12	-0.03 z-score Standard Deviation 0.26	0.02 z-score Standard Deviation 0.15	0.00 z-score Standard Deviation 0.01	0.02 z-score Standard Deviation 0.14
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 Change at Week 16: Mental Component Score	-0.00 z-score Standard Deviation 0.02	0.02 z-score Standard Deviation 0.09	-0.02 z-score Standard Deviation 0.13	0.01 z-score Standard Deviation 0.12	-0.00 z-score Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Median time to discontinuation due to lack of efficacy for participants who discontinued due to lack of efficacy was reported.

Outcome measures

Outcome measures
Measure	Placebo n=4 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=3 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=1 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=4 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Time to Discontinuation Due to Lack of Efficacy	14.0 days Interval 8.0 to 25.0	29.0 days Interval 8.0 to 57.0	8.0 days Interval 8.0 to 8.0	—	16.5 days Interval 8.0 to 21.0

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, and 16

Population: ITT population. LOCF method was used to impute missing values. 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 given time points for each group respectively.

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Incidence of rescue medication use is calculated as any use of rescue medication during the study week in question.

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=73 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=59 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=82 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=81 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Percentage of Participants Who Used Rescue Medication Week 16	43.7 percentage of participants	28.8 percentage of participants	39.0 percentage of participants	35.4 percentage of participants	39.5 percentage of participants
Percentage of Participants Who Used Rescue Medication Week 1	70.0 percentage of participants	54.8 percentage of participants	57.9 percentage of participants	53.1 percentage of participants	50.0 percentage of participants
Percentage of Participants Who Used Rescue Medication Week 2	56.3 percentage of participants	47.9 percentage of participants	52.5 percentage of participants	57.3 percentage of participants	55.0 percentage of participants
Percentage of Participants Who Used Rescue Medication Week 4	43.7 percentage of participants	38.4 percentage of participants	39.0 percentage of participants	40.2 percentage of participants	37.0 percentage of participants
Percentage of Participants Who Used Rescue Medication Week 8	45.1 percentage of participants	30.1 percentage of participants	40.7 percentage of participants	35.4 percentage of participants	42.0 percentage of participants
Percentage of Participants Who Used Rescue Medication Week 12	43.7 percentage of participants	28.8 percentage of participants	39.0 percentage of participants	35.4 percentage of participants	39.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, and 16

Population: ITT population. LOCF method was used to impute missing values. 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 given time points for each group respectively.

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Duration of rescue medication use is calculated as the number of study days per week when any rescue medication was taken.

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=73 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=59 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=82 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=81 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Duration of Rescue Medication Use Week 8	1.6 days/week Standard Deviation 2.41	0.8 days/week Standard Deviation 1.48	1.5 days/week Standard Deviation 2.32	0.8 days/week Standard Deviation 1.61	1.5 days/week Standard Deviation 2.33
Duration of Rescue Medication Use Week 16	1.5 days/week Standard Deviation 2.32	0.8 days/week Standard Deviation 1.53	1.4 days/week Standard Deviation 2.29	0.8 days/week Standard Deviation 1.69	1.4 days/week Standard Deviation 2.33
Duration of Rescue Medication Use Week 1	2.2 days/week Standard Deviation 2.25	1.8 days/week Standard Deviation 2.14	1.7 days/week Standard Deviation 2.01	1.6 days/week Standard Deviation 2.07	1.5 days/week Standard Deviation 2.13
Duration of Rescue Medication Use Week 2	2.0 days/week Standard Deviation 2.27	1.3 days/week Standard Deviation 1.88	1.7 days/week Standard Deviation 2.06	1.5 days/week Standard Deviation 1.72	1.7 days/week Standard Deviation 2.15
Duration of Rescue Medication Use Week 4	1.6 days/week Standard Deviation 2.41	1.0 days/week Standard Deviation 1.63	1.2 days/week Standard Deviation 2.01	1.0 days/week Standard Deviation 1.82	1.4 days/week Standard Deviation 2.33
Duration of Rescue Medication Use Week 12	1.5 days/week Standard Deviation 2.32	0.8 days/week Standard Deviation 1.53	1.4 days/week Standard Deviation 2.29	0.8 days/week Standard Deviation 1.69	1.4 days/week Standard Deviation 2.33

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, and 16

Population: ITT population. LOCF method was used to impute missing values. 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 given time points for each group respectively.

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. The amount of rescue medication taken is the total dose (in mg) of acetaminophen rescue medication over the study week in question.

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=73 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=59 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=82 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=81 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Amount of Rescue Medication Taken Week 2	3077.46 mg/week Standard Deviation 4623.42	1753.42 mg/week Standard Deviation 3210.36	2440.68 mg/week Standard Deviation 3312.83	2189.02 mg/week Standard Deviation 3864.72	2425.00 mg/week Standard Deviation 3693.22
Amount of Rescue Medication Taken Week 8	2464.79 mg/week Standard Deviation 4729.33	1047.95 mg/week Standard Deviation 2636.77	2042.37 mg/week Standard Deviation 4175.35	981.71 mg/week Standard Deviation 2028.26	1777.78 mg/week Standard Deviation 3280.62
Amount of Rescue Medication Taken Week 1	3128.57 mg/week Standard Deviation 3529.06	2609.59 mg/week Standard Deviation 3737.24	2324.56 mg/week Standard Deviation 3291.62	2425.93 mg/week Standard Deviation 3976.58	1631.25 mg/week Standard Deviation 2616.58
Amount of Rescue Medication Taken Week 4	2556.34 mg/week Standard Deviation 4842.93	1239.73 mg/week Standard Deviation 2691.43	1889.83 mg/week Standard Deviation 4100.11	1445.12 mg/week Standard Deviation 2946.02	1716.05 mg/week Standard Deviation 3534.60
Amount of Rescue Medication Taken Week 12	2140.85 mg/week Standard Deviation 4297.16	1061.64 mg/week Standard Deviation 2658.77	1940.68 mg/week Standard Deviation 4132.59	951.22 mg/week Standard Deviation 1888.25	1654.32 mg/week Standard Deviation 3242.92
Amount of Rescue Medication Taken Week 16	2140.85 mg/week Standard Deviation 4297.16	1061.64 mg/week Standard Deviation 2658.77	1940.68 mg/week Standard Deviation 4132.59	951.22 mg/week Standard Deviation 1888.25	1654.32 mg/week Standard Deviation 3242.92

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 112 days after last dose of study treatment

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo).

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	37 Participants	35 Participants	31 Participants	36 Participants	44 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	2 Participants	2 Participants	0 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Laboratory examination included blood chemistry, hematology and urinalysis. Reported results include abnormal laboratory findings without regard to baseline abnormality.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=71 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=61 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=82 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=83 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Number of Participants With Abnormal Laboratory Findings	56 Participants	48 Participants	44 Participants	61 Participants	60 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and heart rate (HR). Number of participants with clinically significant abnormal ECG findings reported as adverse events were presented.

Outcome measures

Outcome measures
Measure	Placebo n=70 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=73 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=62 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

Population: ITT population. LOCF method was used to impute missing values. 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 given time points for each group respectively.

The NIS constitutes the sum of 37 standard items of neuromuscular examination used to assess the muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) are 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 range 0-244 with higher score = more impairment.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=72 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=85 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 Change at Week 8	-0.07 units on a scale Standard Deviation 1.60	-0.14 units on a scale Standard Deviation 2.34	-0.26 units on a scale Standard Deviation 0.99	-0.20 units on a scale Standard Deviation 1.59	-0.39 units on a scale Standard Deviation 2.45
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 Change at Week 16	-0.16 units on a scale Standard Deviation 1.15	-0.63 units on a scale Standard Deviation 2.60	-0.23 units on a scale Standard Deviation 1.26	-0.33 units on a scale Standard Deviation 1.65	-0.62 units on a scale Standard Deviation 2.18
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 Baseline	1.06 units on a scale Standard Deviation 3.13	1.53 units on a scale Standard Deviation 5.09	0.86 units on a scale Standard Deviation 2.40	0.75 units on a scale Standard Deviation 2.69	1.71 units on a scale Standard Deviation 3.85
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 Change at Week 2	-0.09 units on a scale Standard Deviation 2.20	-0.26 units on a scale Standard Deviation 1.79	-0.13 units on a scale Standard Deviation 0.72	-0.08 units on a scale Standard Deviation 1.97	-0.36 units on a scale Standard Deviation 2.17
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 Change at Week 4	0.11 units on a scale Standard Deviation 1.31	-0.14 units on a scale Standard Deviation 2.22	-0.19 units on a scale Standard Deviation 0.87	-0.22 units on a scale Standard Deviation 1.51	0.14 units on a scale Standard Deviation 3.14
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 Change at Week 12	-0.10 units on a scale Standard Deviation 1.47	-0.27 units on a scale Standard Deviation 2.07	-0.32 units on a scale Standard Deviation 1.32	-0.40 units on a scale Standard Deviation 2.34	-0.81 units on a scale Standard Deviation 2.80
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 Change at Week 24	-0.19 units on a scale Standard Deviation 2.02	-0.86 units on a scale Standard Deviation 3.05	-0.55 units on a scale Standard Deviation 1.53	-0.52 units on a scale Standard Deviation 2.01	-0.90 units on a scale Standard Deviation 2.34

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 8, 16, 24 or Early Termination

Population: ITT population. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure at any time point and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group 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). Same participant may have positive ADA result at more than 1 time point.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=66 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=87 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=85 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Number of Participants With Anti-drug Antibodies (ADA) Baseline	0 Participants	0 Participants	1 Participants	0 Participants	—
Number of Participants With Anti-drug Antibodies (ADA) Week 8	1 Participants	0 Participants	1 Participants	0 Participants	—
Number of Participants With Anti-drug Antibodies (ADA) Week 16	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Anti-drug Antibodies (ADA) Week 24 (End of treatment)	1 Participants	3 Participants	1 Participants	1 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 24

Population: Data was not summarized separately and any clinically significant abnormality in physical finding was reported as an adverse event in this study.

Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat, lungs and thyroid.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, pulse rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs reported as adverse events were presented.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=73 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Number of Participants With Clinically Significant Abnormality in Vital Signs	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, 16, and 24

Population: ITT population. 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 given time points for each group respectively.

The injection and infusion site reactions were assessed based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after administration of subcutaneous injection or intravenous infusion.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=72 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=85 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Number of Participants With Injection and Infusion Site Reactions Baseline: Infusion site	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 1: Injection site	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Injection and Infusion Site Reactions Week 8: Infusion site	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 12: Infusion site	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 16: Injection site	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 24: Injection site	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Baseline: Injection site	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Injection and Infusion Site Reactions Week 1: Infusion site	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Injection and Infusion Site Reactions Week 2: Injection site	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Injection and Infusion Site Reactions Week 2: Infusion site	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 4: Injection site	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 4: Infusion site	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 8: Injection site	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 12: Injection site	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 16: Infusion site	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 24: Infusion site	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (pre-dose), Weeks 1, 2, 4, 8 (pre-dose), 12, 16, 24 or End of treatment

Population: ITT population. 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 given time points for each group respectively.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=60 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=82 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=80 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Plasma Tanezumab Concentration Week 1	265.7 nanogram per milliliter (ng/mL) Standard Deviation 132.17	480.7 nanogram per milliliter (ng/mL) Standard Deviation 249.53	1015 nanogram per milliliter (ng/mL) Standard Deviation 429.96	1700 nanogram per milliliter (ng/mL) Standard Deviation 874.30	—
Plasma Tanezumab Concentration Week 2	270.2 nanogram per milliliter (ng/mL) Standard Deviation 110.93	486.3 nanogram per milliliter (ng/mL) Standard Deviation 160.85	1012 nanogram per milliliter (ng/mL) Standard Deviation 350.47	1378 nanogram per milliliter (ng/mL) Standard Deviation 772.25	—
Plasma Tanezumab Concentration Week 24 (End of treatment)	17.58 nanogram per milliliter (ng/mL) Standard Deviation 38.959	58.57 nanogram per milliliter (ng/mL) Standard Deviation 142.04	113.2 nanogram per milliliter (ng/mL) Standard Deviation 139.49	264.2 nanogram per milliliter (ng/mL) Standard Deviation 960.42	—
Plasma Tanezumab Concentration Baseline: pre-dose	12.65 nanogram per milliliter (ng/mL) Standard Deviation 36.610	14.43 nanogram per milliliter (ng/mL) Standard Deviation 45.560	30.90 nanogram per milliliter (ng/mL) Standard Deviation 81.647	138.5 nanogram per milliliter (ng/mL) Standard Deviation 820.35	—
Plasma Tanezumab Concentration Week 4	207.4 nanogram per milliliter (ng/mL) Standard Deviation 95.228	371.8 nanogram per milliliter (ng/mL) Standard Deviation 185.63	791.1 nanogram per milliliter (ng/mL) Standard Deviation 228.97	887.5 nanogram per milliliter (ng/mL) Standard Deviation 280.47	—
Plasma Tanezumab Concentration Week 8: pre-dose	81.51 nanogram per milliliter (ng/mL) Standard Deviation 59.632	158.1 nanogram per milliliter (ng/mL) Standard Deviation 89.087	370.2 nanogram per milliliter (ng/mL) Standard Deviation 176.99	428.1 nanogram per milliliter (ng/mL) Standard Deviation 213.49	—
Plasma Tanezumab Concentration Week 12	52.55 nanogram per milliliter (ng/mL) Standard Deviation 92.620	88.13 nanogram per milliliter (ng/mL) Standard Deviation 150.90	323.8 nanogram per milliliter (ng/mL) Standard Deviation 349.02	304.8 nanogram per milliliter (ng/mL) Standard Deviation 286.23	—
Plasma Tanezumab Concentration Week 16	99.73 nanogram per milliliter (ng/mL) Standard Deviation 70.613	257.0 nanogram per milliliter (ng/mL) Standard Deviation 298.20	628.6 nanogram per milliliter (ng/mL) Standard Deviation 244.38	501.7 nanogram per milliliter (ng/mL) Standard Deviation 218.74	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (pre-dose), Weeks 1, 2, 4, 8 (pre-dose), 12, 16, and 24 or End of treatment

Population: ITT population. 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 given time points for each group respectively.

Serum samples were analyzed for determining total and free (unbound) NGF concentration. Total NGF was analyzed using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method and free (unbound) NGF was analyzed using a validated, sensitive, and specific electrochemiluminescence (ECL) ligand binding assay.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=69 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=60 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=82 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=80 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Total and Free Nerve Growth Factor (NGF) Concentration Baseline (pre-dose): Free NGF	1.7 picogram per milliliter (pg/mL) Standard Deviation 0.9	1.8 picogram per milliliter (pg/mL) Standard Deviation 1.0	1.6 picogram per milliliter (pg/mL) Standard Deviation 0.8	1.5 picogram per milliliter (pg/mL) Standard Deviation 0.7	1.5 picogram per milliliter (pg/mL) Standard Deviation 0.8
Total and Free Nerve Growth Factor (NGF) Concentration Week 1: Free NGF	1.6 picogram per milliliter (pg/mL) Standard Deviation 1.2	1.1 picogram per milliliter (pg/mL) Standard Deviation 1.1	0.9 picogram per milliliter (pg/mL) Standard Deviation 2.1	0.2 picogram per milliliter (pg/mL) Standard Deviation 0.6	0.1 picogram per milliliter (pg/mL) Standard Deviation 0.4
Total and Free Nerve Growth Factor (NGF) Concentration Week 2: Total NGF	35.0 picogram per milliliter (pg/mL) Standard Deviation 13.8	1202 picogram per milliliter (pg/mL) Standard Deviation 400	1497 picogram per milliliter (pg/mL) Standard Deviation 532	1867 picogram per milliliter (pg/mL) Standard Deviation 588	2149 picogram per milliliter (pg/mL) Standard Deviation 601
Total and Free Nerve Growth Factor (NGF) Concentration Week 2: Free NGF	1.7 picogram per milliliter (pg/mL) Standard Deviation 0.7	2.5 picogram per milliliter (pg/mL) Standard Deviation 1.4	2.1 picogram per milliliter (pg/mL) Standard Deviation 1.4	0.8 picogram per milliliter (pg/mL) Standard Deviation 1.0	0.8 picogram per milliliter (pg/mL) Standard Deviation 1.2
Total and Free Nerve Growth Factor (NGF) Concentration Week 4: Free NGF	1.7 picogram per milliliter (pg/mL) Standard Deviation 1.0	3.3 picogram per milliliter (pg/mL) Standard Deviation 1.5	3.4 picogram per milliliter (pg/mL) Standard Deviation 1.4	2.5 picogram per milliliter (pg/mL) Standard Deviation 1.3	2.7 picogram per milliliter (pg/mL) Standard Deviation 1.4
Total and Free Nerve Growth Factor (NGF) Concentration Week 8 (pre-dose): Total NGF	35.7 picogram per milliliter (pg/mL) Standard Deviation 12.8	1388 picogram per milliliter (pg/mL) Standard Deviation 606	1867 picogram per milliliter (pg/mL) Standard Deviation 890	2544 picogram per milliliter (pg/mL) Standard Deviation 869	2724 picogram per milliliter (pg/mL) Standard Deviation 931
Total and Free Nerve Growth Factor (NGF) Concentration Week 24 (End of treatment): Free NGF	1.6 picogram per milliliter (pg/mL) Standard Deviation 1.0	1.5 picogram per milliliter (pg/mL) Standard Deviation 0.9	1.5 picogram per milliliter (pg/mL) Standard Deviation 1.0	2.1 picogram per milliliter (pg/mL) Standard Deviation 2.0	2.0 picogram per milliliter (pg/mL) Standard Deviation 1.5
Total and Free Nerve Growth Factor (NGF) Concentration Baseline (pre-dose): Total NGF	34.9 picogram per milliliter (pg/mL) Standard Deviation 10.1	44.6 picogram per milliliter (pg/mL) Standard Deviation 41.8	79.2 picogram per milliliter (pg/mL) Standard Deviation 276	35.1 picogram per milliliter (pg/mL) Standard Deviation 8.7	32.7 picogram per milliliter (pg/mL) Standard Deviation 9.2
Total and Free Nerve Growth Factor (NGF) Concentration Week 1: Total NGF	71.3 picogram per milliliter (pg/mL) Standard Deviation 232	742 picogram per milliliter (pg/mL) Standard Deviation 302	941 picogram per milliliter (pg/mL) Standard Deviation 419	1196 picogram per milliliter (pg/mL) Standard Deviation 452	1432 picogram per milliliter (pg/mL) Standard Deviation 477
Total and Free Nerve Growth Factor (NGF) Concentration Week 4: Total NGF	35.5 picogram per milliliter (pg/mL) Standard Deviation 13.4	1596 picogram per milliliter (pg/mL) Standard Deviation 542	2108 picogram per milliliter (pg/mL) Standard Deviation 1129	2554 picogram per milliliter (pg/mL) Standard Deviation 828	2629 picogram per milliliter (pg/mL) Standard Deviation 750
Total and Free Nerve Growth Factor (NGF) Concentration Week 8 (pre-dose): Free NGF	1.6 picogram per milliliter (pg/mL) Standard Deviation 0.8	2.3 picogram per milliliter (pg/mL) Standard Deviation 1.3	3.1 picogram per milliliter (pg/mL) Standard Deviation 1.4	4.5 picogram per milliliter (pg/mL) Standard Deviation 2.5	4.7 picogram per milliliter (pg/mL) Standard Deviation 1.9
Total and Free Nerve Growth Factor (NGF) Concentration Week 12: Total NGF	33.7 picogram per milliliter (pg/mL) Standard Deviation 13.1	798 picogram per milliliter (pg/mL) Standard Deviation 768	1216 picogram per milliliter (pg/mL) Standard Deviation 751	2253 picogram per milliliter (pg/mL) Standard Deviation 1024	2521 picogram per milliliter (pg/mL) Standard Deviation 1166
Total and Free Nerve Growth Factor (NGF) Concentration Week 12: Free NGF	1.7 picogram per milliliter (pg/mL) Standard Deviation 0.9	1.4 picogram per milliliter (pg/mL) Standard Deviation 1.3	1.9 picogram per milliliter (pg/mL) Standard Deviation 1.6	3.1 picogram per milliliter (pg/mL) Standard Deviation 1.8	3.5 picogram per milliliter (pg/mL) Standard Deviation 1.8
Total and Free Nerve Growth Factor (NGF) Concentration Week 16: Total NGF	35.2 picogram per milliliter (pg/mL) Standard Deviation 10.1	1900 picogram per milliliter (pg/mL) Standard Deviation 1428	1206 picogram per milliliter (pg/mL) Standard Deviation 830	3320 picogram per milliliter (pg/mL) Standard Deviation 502	4082 picogram per milliliter (pg/mL) Standard Deviation 1940
Total and Free Nerve Growth Factor (NGF) Concentration Week 16: Free NGF	2.0 picogram per milliliter (pg/mL) Standard Deviation 0.7	1.9 picogram per milliliter (pg/mL) Standard Deviation 1.2	3.7 picogram per milliliter (pg/mL) Standard Deviation 4.1	5.9 picogram per milliliter (pg/mL) Standard Deviation 4.3	5.3 picogram per milliliter (pg/mL) Standard Deviation 1.5
Total and Free Nerve Growth Factor (NGF) Concentration Week 24 (End of treatment): Total NGF	31.7 picogram per milliliter (pg/mL) Standard Deviation 10.9	251 picogram per milliliter (pg/mL) Standard Deviation 323	489 picogram per milliliter (pg/mL) Standard Deviation 634	1114 picogram per milliliter (pg/mL) Standard Deviation 737	1445 picogram per milliliter (pg/mL) Standard Deviation 997

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 8

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo).

Number of participants were reported based on the maximum number of intravenous or subcutaneous doses of either tanezumab or placebo received.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 Participants Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Number of Participants With Intravenous or Subcutaneous Doses of Study Medication 1 dose	65 Participants	67 Participants	56 Participants	78 Participants	77 Participants
Number of Participants With Intravenous or Subcutaneous Doses of Study Medication 2 doses	7 Participants	7 Participants	7 Participants	8 Participants	7 Participants

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Tanezumab 2.5 mg Subcutaneous Injection

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Tanezumab 5 mg Subcutaneous Injection

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Tanezumab 10 mg Subcutaneous Injection

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Tanezumab 10 mg Intravenous Infusion

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=72 participants at risk Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 participants at risk Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 participants at risk Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 participants at risk Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 participants at risk Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
General disorders Oedema peripheral	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.4% 1/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	1.4% 1/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Other adverse events

Other adverse events
Measure	Placebo n=72 participants at risk Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 2.5 mg Subcutaneous Injection n=74 participants at risk Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 5 mg Subcutaneous Injection n=63 participants at risk Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Subcutaneous Injection n=86 participants at risk Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab 10 mg Intravenous Infusion n=84 participants at risk Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Infections and infestations Upper respiratory tract infection	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.3% 2/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.1% 3/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Nausea	2.8% 2/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Chills	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Fatigue	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.6% 3/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Influenza like illness	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Infusion site reaction	1.4% 1/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Injection site reaction	2.8% 2/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.7% 4/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.6% 3/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Oedema peripheral	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 3/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.7% 4/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Bronchitis	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.3% 2/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Contusion	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.2% 2/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Muscle strain	1.4% 1/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.3% 2/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 4/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.4% 4/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 7/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.8% 5/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.0% 5/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.2% 2/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Joint swelling	5.6% 4/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.2% 2/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.5% 3/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	1.4% 1/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.2% 2/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.2% 2/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.3% 2/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	1.4% 1/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.6% 4/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	2.8% 2/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 3/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.7% 4/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.6% 3/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.3% 2/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.2% 2/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Burning sensation	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.2% 2/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Dizziness	4.2% 3/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Headache	4.2% 3/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.8% 5/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.8% 5/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Hypoaesthesia	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.0% 6/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Paraesthesia	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.2% 2/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.0% 6/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.1% 6/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Sensory disturbance	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.3% 2/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Depression	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.4% 2/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	2.8% 2/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/72 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.2% 1/86 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/84 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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