Trial Outcomes & Findings for Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis (NCT NCT00762463)

Results Overview

100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of less than (\<) 0 indicated improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

240 participants

Primary outcome timeframe

Baseline, Week 6

Results posted on

2021-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	Celecoxib 200 mg Celecoxib 200 milligram (mg) capsule once daily	Diclofenac SR 75 mg Diclofenac sustained release (SR) 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Double-blind Phase (Baseline to Week 6) STARTED	120	120	0	0
Double-blind Phase (Baseline to Week 6) COMPLETED	113	110	0	0
Double-blind Phase (Baseline to Week 6) NOT COMPLETED	7	10	0	0
Enrollment in Extension Phase (Week 6) STARTED	113	110	0	0
Enrollment in Extension Phase (Week 6) COMPLETED	109	109	0	0
Enrollment in Extension Phase (Week 6) NOT COMPLETED	4	1	0	0
Extension Phase (Week 6 to Week 12) STARTED	55	55	54	54
Extension Phase (Week 6 to Week 12) COMPLETED	52	54	50	52
Extension Phase (Week 6 to Week 12) NOT COMPLETED	3	1	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Celecoxib 200 mg Celecoxib 200 milligram (mg) capsule once daily	Diclofenac SR 75 mg Diclofenac sustained release (SR) 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Double-blind Phase (Baseline to Week 6) Insufficient clinical response	2	2	0	0
Double-blind Phase (Baseline to Week 6) No longer willing to participate	3	4	0	0
Double-blind Phase (Baseline to Week 6) Adverse Event	2	4	0	0
Enrollment in Extension Phase (Week 6) Did not sign 2nd informed consent form	4	1	0	0
Extension Phase (Week 6 to Week 12) Lost to Follow-up	1	0	1	0
Extension Phase (Week 6 to Week 12) Insufficient clinical response	1	1	0	1
Extension Phase (Week 6 to Week 12) No longer willing to participate	1	0	3	0
Extension Phase (Week 6 to Week 12) Other	0	0	0	1

Baseline Characteristics

Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Celecoxib 200 mg n=120 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=120 Participants Diclofenac SR 75 mg tablet once daily	Total n=240 Participants Total of all reporting groups
Age, Customized 18 - 44 years	109 participants n=99 Participants	109 participants n=107 Participants	218 participants n=206 Participants
Age, Customized 45 - 64 years	11 participants n=99 Participants	11 participants n=107 Participants	22 participants n=206 Participants
Sex: Female, Male Female	15 Participants n=99 Participants	19 Participants n=107 Participants	34 Participants n=206 Participants
Sex: Female, Male Male	105 Participants n=99 Participants	101 Participants n=107 Participants	206 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Per-Protocol (PP): All randomized participants who received at least one dose of study medication, and had global pain intensity assessment at Week 6 and no major protocol deviations.

100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of less than (\<) 0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=111 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=108 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6	-23.8 mm Standard Error 1.98	-27.1 mm Standard Error 2.02	—	—

PRIMARY outcome

Timeframe: Baseline

Population: PP

100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Lower scores indicated less pain.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=111 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=108 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Participant's Assessment of Global Pain Intensity at Baseline	62.9 mm Standard Deviation 12.68	63.6 mm Standard Deviation 13.38	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4

Population: Full Analysis Set (FAS). Number of participants analyzed (N) = total evaluable participants. n = evaluable participants at that time point.

100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=117 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=115 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4 Week 2 (n=116, 115)	-18.6 mm Standard Error 1.78	-17.9 mm Standard Error 1.79	—	—
Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4 Week 4 (n=117, 115)	-20.7 mm Standard Error 1.86	-23.3 mm Standard Error 1.89	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS. n = evaluable participants at that time point.

100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Lower scores indicated less pain. Change from baseline of \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=55 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=55 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg n=54 Participants Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg n=54 Participants Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 Baseline (n=55, 55, 54, 54)	63.4 mm Standard Deviation 13.58	61.1 mm Standard Deviation 13.08	63.4 mm Standard Deviation 12.05	65.6 mm Standard Deviation 13.26
Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 Change from Baseline at Week 12 (n=52, 54, 46, 51)	-28.4 mm Standard Deviation 21.39	-30.9 mm Standard Deviation 24.24	-20.8 mm Standard Deviation 21.86	-28.1 mm Standard Deviation 25.96

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6

Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.

5-point Likert scale scores specified participant's current situation in response to the following question "Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today?" 1=very good to 5=very poor. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=117 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=115 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6 Week 2 (n=116, 115)	-0.4 units on a scale Standard Error 0.06	-0.4 units on a scale Standard Error 0.06	—	—
Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6 Week 4 (n=117, 115)	-0.3 units on a scale Standard Error 0.06	-0.4 units on a scale Standard Error 0.06	—	—
Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6 Week 6 (n=117, 115)	-0.3 units on a scale Standard Error 0.06	-0.4 units on a scale Standard Error 0.06	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS. n = evaluable participants at that time point.

5-point Likert scale scores specified participant's current situation in response to the following question "Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today?" 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=55 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=55 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg n=54 Participants Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg n=54 Participants Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 Baseline (n=55, 55, 54, 54)	3.1 units on a scale Standard Deviation 0.83	3.0 units on a scale Standard Deviation 0.64	3.2 units on a scale Standard Deviation 0.66	3.2 units on a scale Standard Deviation 0.70
Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 Change from Baseline at Week 12 (n=52, 54, 46, 51)	-0.6 units on a scale Standard Deviation 0.99	-0.6 units on a scale Standard Deviation 0.78	-0.4 units on a scale Standard Deviation 0.71	-0.6 units on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6

Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.

5-point Likert scale scores specified physician's subjective assessment on how overall ankylosing spondylitis appeared at the time of participant's visit and participant's disease signs. 1=very good to 5=very poor. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=117 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=115 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6 Week 2 (n=116, 115)	-0.4 units on a scale Standard Error 0.05	-0.4 units on a scale Standard Error 0.05	—	—
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6 Week 4 (n=117, 115)	-0.4 units on a scale Standard Error 0.05	-0.5 units on a scale Standard Error 0.05	—	—
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6 Week 6 (n=117, 115)	-0.5 units on a scale Standard Error 0.06	-0.5 units on a scale Standard Error 0.06	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS. n = evaluable participants at that time point.

5-point Likert scale scores specified physician's subjective assessment on how the overall ankylosing spondylitis appeared at the time of the participant's visit and participant's disease signs. 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=55 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=55 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg n=54 Participants Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg n=54 Participants Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 Baseline (n=55, 55, 54, 54)	3.2 units on a scale Standard Deviation 0.57	3.0 units on a scale Standard Deviation 0.45	3.2 units on a scale Standard Deviation 0.43	3.3 units on a scale Standard Deviation 0.50
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 Change from Baseline at Week 12 (n=52, 54, 46, 51)	-0.7 units on a scale Standard Deviation 0.60	-0.5 units on a scale Standard Deviation 0.64	-0.5 units on a scale Standard Deviation 0.51	-0.7 units on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6

Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.

Bath Ankylosing Spondylitis Functional Index (BASFI) was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=117 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=115 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6 Week 2 (n=116, 115)	-0.3 mm Standard Error 0.13	-0.3 mm Standard Error 0.13	—	—
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6 Week 4 (n=117, 115)	-0.4 mm Standard Error 0.14	-0.6 mm Standard Error 0.14	—	—
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6 Week 6 (n=117, 115)	-0.5 mm Standard Error 0.15	-0.8 mm Standard Error 0.15	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS. n = evaluable participants at that time point.

BASFI was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Lower scores indicated better functional health. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=55 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=55 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg n=54 Participants Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg n=54 Participants Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in BASFI at Week 12 Baseline (n=55, 55, 54, 54)	3.4 mm Standard Deviation 1.98	3.5 mm Standard Deviation 2.13	3.5 mm Standard Deviation 1.83	3.5 mm Standard Deviation 2.25
Change From Baseline in BASFI at Week 12 Change from Baseline at Week 12 (n=52, 54, 46, 51)	-0.9 mm Standard Deviation 1.78	-1.0 mm Standard Deviation 1.64	-0.6 mm Standard Deviation 1.97	-1.0 mm Standard Deviation 2.30

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6

Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.

Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was comprised of 6 specific questions, each answered on a 10-mm VAS scale. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=117 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=115 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6 Week 2 (n=116, 115)	-0.8 mm Standard Error 0.14	-0.9 mm Standard Error 0.14	—	—
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6 Week 4 (n=117, 115)	-0.9 mm Standard Error 0.15	-1.1 mm Standard Error 0.15	—	—
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6 Week 6 (n=117, 115)	-1.1 mm Standard Error 0.16	-1.4 mm Standard Error 0.16	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS. n = evaluable participants at that time point.

BASDAI is comprised of 6 specific questions, each answered on a 10-mm VAS. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Lower scores indicated better health. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=55 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=55 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg n=54 Participants Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg n=54 Participants Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in BASDAI at Week 12 Baseline (n=55, 55, 54, 54)	4.71 mm Standard Deviation 1.79	4.9 mm Standard Deviation 1.80	4.7 mm Standard Deviation 1.48	4.9 mm Standard Deviation 1.88
Change From Baseline in BASDAI at Week 12 Change from Baseline at Week 12 (n=52, 54, 46, 51)	-1.7 mm Standard Deviation 1.86	-2.1 mm Standard Deviation 1.94	-0.6 mm Standard Deviation 1.87	-1.4 mm Standard Deviation 2.14

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 12

Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.

Percentages of participants who demonstrated an improvement of greater than or equal to (≥) 20% from baseline and an absolute improvement of ≥10 mm from baseline on a 100-mm VAS in ≥3 of the 4 domains proposed by the Ankylosing Spondylitis Assessment Working Group (ASAS-20).

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=116 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=114 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg n=55 Participants Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg n=55 Participants Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 Week 2 (n=115, 114)	23.5 percentage of participants	25.4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 Week 4 (n=116, 114)	26.7 percentage of participants	31.6 percentage of participants	0 percentage of participants	0 percentage of participants
Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 Week 6 (n=54, 54, 54, 54)	40.7 percentage of participants	42.6 percentage of participants	22.2 percentage of participants	29.6 percentage of participants
Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 Week 12 (n=51, 53, 46, 51)	49.0 percentage of participants	47.2 percentage of participants	32.6 percentage of participants	37.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6

Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.

100-mm VAS scores specified participant's nocturnal pain in response to the following question "Did you have any pain in the neck, back or hips during the previous night?" 0=no pain to 100=worst pain possible. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=117 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=115 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6 Week 2 (n=116, 115)	-12.0 mm Standard Error 1.90	-16.3 mm Standard Error 1.91	—	—
Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6 Week 4 (n=117, 115)	-14.5 mm Standard Error 1.94	-17.1 mm Standard Error 1.96	—	—
Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6 Week 6 (n=117, 115)	-15.4 mm Standard Error 1.95	-19.4 mm Standard Error 1.98	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS. n = evaluable participants at that time point.

100-mm VAS scores specified participant's nocturnal pain in response to the following question "Did you have any pain in the neck, back or hips during the previous night?" 0=no pain to 100=worst pain possible. Lower scores indicated less pain. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=55 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=55 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg n=54 Participants Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg n=54 Participants Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Nocturnal Pain at Week 12 Change from Baseline at Week 12 (n=52, 54, 46, 51)	-19.4 mm Standard Deviation 22.54	-27.5 mm Standard Deviation 25.62	-12.5 mm Standard Deviation 20.31	-22.6 mm Standard Deviation 30.36
Change From Baseline in Nocturnal Pain at Week 12 Baseline (n=55, 55, 54, 54)	52.2 mm Standard Deviation 20.45	55.1 mm Standard Deviation 19.24	54.5 mm Standard Deviation 20.14	61.5 mm Standard Deviation 19.17

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6

Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.

Fingertips to floor distance measured in centimeter (cm) from the tip of the fingers to the floor with participants standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=118 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=115 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6 Week 2 (n=117, 115)	-1.6 cm Standard Error 0.62	-1.6 cm Standard Error 0.62	—	—
Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6 Week 4 (n=118, 115)	-1.9 cm Standard Error 0.69	-2.2 cm Standard Error 0.71	—	—
Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6 Week 6 (n=118, 115)	-2.8 cm Standard Error 0.67	-3.1 cm Standard Error 0.69	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS. n = evaluable participants at that time point.

Fingertips to floor distance measured in cm from the tip of the fingers to the floor with participant standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Lower scores indicated better health. Change from baseline \<0 represented improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=55 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=55 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg n=54 Participants Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg n=54 Participants Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Fingertips to Floor Distance at Week 12 Baseline (n=55, 55, 54, 54)	14.8 cm Standard Deviation 12.89	17.6 cm Standard Deviation 15.23	22.9 cm Standard Deviation 19.49	14.6 cm Standard Deviation 14.48
Change From Baseline in Fingertips to Floor Distance at Week 12 Change from Baseline at Week 12 (n=52, 54, 46, 51)	-3.0 cm Standard Deviation 9.38	-3.7 cm Standard Deviation 6.82	-3.1 cm Standard Deviation 8.18	-1.3 cm Standard Deviation 7.75

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6

Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.

Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Change from baseline greater than (\>) 0 represented improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=118 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=115 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Chest Expansion at Weeks 2, 4, and 6 Week 2 (n=117, 115)	0.2 cm Standard Error 0.08	0.3 cm Standard Error 0.08	—	—
Change From Baseline in Chest Expansion at Weeks 2, 4, and 6 Week 4 (n=118, 115)	0.6 cm Standard Error 0.09	0.4 cm Standard Error 0.09	—	—
Change From Baseline in Chest Expansion at Weeks 2, 4, and 6 Week 6 (n=118, 115)	0.7 cm Standard Error 0.10	0.6 cm Standard Error 0.10	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS. n = evaluable participants at that time point.

Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Higher scores indicate better health. Change from baseline greater than (\>) 0 represented improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=55 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=55 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg n=54 Participants Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg n=54 Participants Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Chest Expansion at Week 12 Baseline (n=55, 55, 54, 54)	3.9 cm Standard Deviation 1.93	3.8 cm Standard Deviation 1.63	3.6 cm Standard Deviation 1.82	3.8 cm Standard Deviation 1.62
Change From Baseline in Chest Expansion at Week 12 Change from Baseline at Week 12 (n=52, 54, 46, 51)	0.8 cm Standard Deviation 1.26	0.8 cm Standard Deviation 1.39	0.8 cm Standard Deviation 1.29	0.8 cm Standard Deviation 1.02

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: FAS

Erythrocyte Sedimentation Rate (ESR) was a laboratory test that providee a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h). Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=108 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=110 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6	-2.5 mm/h Standard Error 1.30	-1.8 mm/h Standard Error 1.30	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS. n = evaluable participants at that time point.

ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Lower values indicated better health. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=54 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=54 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg n=52 Participants Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg n=54 Participants Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in ESR at Week 12 Baseline (n=54, 54, 52, 54)	20.9 mm/h Standard Deviation 14.60	20.8 mm/h Standard Deviation 18.98	22.8 mm/h Standard Deviation 21.99	23.6 mm/h Standard Deviation 19.64
Change From Baseline in ESR at Week 12 Change from Baseline at Week 12 (n=45, 44, 41, 43)	-3.5 mm/h Standard Deviation 13.96	-1.3 mm/h Standard Deviation 11.14	-6.3 mm/h Standard Deviation 13.46	-0.7 mm/h Standard Deviation 19.47

SECONDARY outcome

Timeframe: Baseline, 6 Weeks

Population: FAS

C-Reactive Protein (CRP) was a marker of inflammation, measured in milligram per liter (mg/L). Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=109 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=110 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in C-Reactive Protein (CRP) at Week 6	-4.16 mg/L Standard Error 1.587	-2.72 mg/L Standard Error 1.600	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS. n = evaluable participants at that time point.

CRP was a marker of inflammation. Lower values indicated better health. Change from baseline \<0 indicated improvement.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=53 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=55 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg n=53 Participants Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg n=54 Participants Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Change From Baseline in CRP at Week 12 Baseline (n=53, 55, 53, 54)	18.53 mg/L Standard Deviation 28.749	15.84 mg/L Standard Deviation 20.464	18.80 mg/L Standard Deviation 25.774	21.01 mg/L Standard Deviation 21.360
Change From Baseline in CRP at Week 12 Change from Baseline at Week 12 (n=47, 49, 42, 47)	-4.58 mg/L Standard Deviation 9.682	-2.99 mg/L Standard Deviation 13.242	-4.77 mg/L Standard Deviation 24.656	-2.13 mg/L Standard Deviation 20.879

SECONDARY outcome

Timeframe: Week 6

Population: FAS

Percentage of participants who concomitantly took at least 1 paracetamol tablet as rescue medication at Week 6

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=120 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=120 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Percentage of Participants With Concomitant Use of Paracetamol	2.5 percentage of participants	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 6

Population: FAS

Calculated as days on rescue medication divided by days of exposure in the study at the end of Week 6.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=120 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=120 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Percentage of Days With Concomitant Administration of Paracetamol	0.1 percentage of days Standard Deviation 0.08	0.0 percentage of days Standard Deviation 0.00	—	—

SECONDARY outcome

Timeframe: Week 6

Population: FAS

Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study.

Outcome measures

Outcome measures
Measure	Celecoxib 200 mg n=120 Participants Celecoxib 200 mg capsule once daily	Diclofenac SR 75 mg n=120 Participants Diclofenac SR 75 mg tablet once daily	Celecoxib 200 mg, Then Celecoxib 400 mg Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Paracetamol Tablets Taken Per Day by Participant	0.2 tablets per day Standard Deviation 0.16	0.0 tablets per day Standard Deviation 0.00	—	—

Adverse Events

Celecoxib 200 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Diclofenac SR 75 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Celecoxib 200 mg, Then Celecoxib 200 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diclofenac SR 75 mg, Then Diclofenac SR 75 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Celecoxib 200 mg, Then Celecoxib 400 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Diclofenac SR 75 mg, Then Celecoxib 400 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Celecoxib 200 mg n=120 participants at risk Celecoxib 200 mg capsule once daily from baseline to Week 6	Diclofenac SR 75 mg n=120 participants at risk Diclofenac SR 75 mg tablet once daily from baseline to Week 6	Celecoxib 200 mg, Then Celecoxib 200 mg n=54 participants at risk Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 200 mg capsule once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Diclofenac SR 75 mg n=55 participants at risk Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Diclofenac SR 75 mg tablet once daily from Week 6 to Week 12	Celecoxib 200 mg, Then Celecoxib 400 mg n=53 participants at risk Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12	Diclofenac SR 75 mg, Then Celecoxib 400 mg n=54 participants at risk Diclofenac SR 75 mg tablet once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Blood and lymphatic system disorders Anaemia	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukopenia	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Wolff-Parkinson-White Syndrome	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Uveitis	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal discomfort	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 2/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Mouth ulceration	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 2/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	3.3% 4/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 2/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 2/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Red blood cell urine positive	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Transaminases increased	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations White blood cell count decreased	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders VIIth nerve paralysis	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash generalised	0.83% 1/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious 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