Trial Outcomes & Findings for Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee. (NCT NCT03988023)

Last Updated: 2022-10-05

Results Overview

Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1043 participants

Primary outcome timeframe

Scored at Baseline and 12 Week

Results posted on

2022-10-05

Participant Flow

Recruitment of subjects occurred in medical clinics from June 2019 to March 2020.

No pharmacological or non-pharmacological treatment targeting osteoarthritis (OA) started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study.

Participant milestones

Participant milestones
Measure	Ampion 4 mL Dose 4 mL Injection of Ampion	Placebo 4 mL Dose 4 mL Injection of Placebo
Overall Study STARTED	520	523
Overall Study COMPLETED	235	235
Overall Study NOT COMPLETED	285	288

Reasons for withdrawal

Reasons for withdrawal
Measure	Ampion 4 mL Dose 4 mL Injection of Ampion	Placebo 4 mL Dose 4 mL Injection of Placebo
Overall Study Non-compliance	3	0
Overall Study Withdrawal by Subject	39	37
Overall Study Adverse Event	0	2
Overall Study Physician Decision	0	1
Overall Study Lost to Follow-up	5	8
Overall Study Sponsor decision to terminate follow up	10	12
Overall Study Lack of Efficacy	3	1
Overall Study COVID-19 pandemic	225	227

Baseline Characteristics

Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ampion 4 mL Dose n=520 Participants 4 mL Injection of Ampion	Placebo 4 mL Dose n=523 Participants 4 mL Injection of Placebo	Total n=1043 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 9.2 • n=5 Participants	64.7 years STANDARD_DEVIATION 9.2 • n=7 Participants	64.7 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	304 Participants n=5 Participants	342 Participants n=7 Participants	646 Participants n=5 Participants
Sex: Female, Male Male	216 Participants n=5 Participants	181 Participants n=7 Participants	397 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	23 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	491 Participants n=5 Participants	495 Participants n=7 Participants	986 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	98 Participants n=5 Participants	83 Participants n=7 Participants	181 Participants n=5 Participants
Race (NIH/OMB) White	410 Participants n=5 Participants	429 Participants n=7 Participants	839 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	520 participants n=5 Participants	523 participants n=7 Participants	1043 participants n=5 Participants
Body Mass Index (BMI)	33.8 kg/m^2 STANDARD_DEVIATION 8.1 • n=5 Participants	34.7 kg/m^2 STANDARD_DEVIATION 8.5 • n=7 Participants	34.3 kg/m^2 STANDARD_DEVIATION 8.3 • n=5 Participants
WOMAC Pain	2.34 Score on a scale STANDARD_DEVIATION 0.69 • n=5 Participants	2.40 Score on a scale STANDARD_DEVIATION 0.70 • n=7 Participants	2.37 Score on a scale STANDARD_DEVIATION .69 • n=5 Participants
WOMAC Function	2.43 Score on a scale STANDARD_DEVIATION 0.70 • n=5 Participants	2.45 Score on a scale STANDARD_DEVIATION 0.72 • n=7 Participants	2.44 Score on a scale STANDARD_DEVIATION 0.71 • n=5 Participants

PRIMARY outcome

Timeframe: Scored at Baseline and 12 Week

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	Ampion 4 mL Dose n=520 Participants 4 mL Injection of Ampion	Placebo 4 mL Dose n=523 Participants 4 mL Injection of Placebo
Change in Knee Pain	-0.66 Score on a scale Interval -0.73 to -0.61	-0.71 Score on a scale Interval -0.76 to -0.64

PRIMARY outcome

Timeframe: Scored at Baseline and 12 weeks.

Population: Intent to Treat (ITT)

Mean change in WOMAC C function score (Western Ontario and McMaster Universities Arthritis Index) from Baseline to 12 weeks. 5-point Likert scale indicating limitation of function (0=none to 4=extreme). A greater negative value indicates a improvement in function.

Outcome measures

Outcome measures
Measure	Ampion 4 mL Dose n=520 Participants 4 mL Injection of Ampion	Placebo 4 mL Dose n=523 Participants 4 mL Injection of Placebo
Change in Knee Function	-0.68 Score on a scale Interval -0.75 to -0.62	-0.73 Score on a scale Interval -0.79 to -0.67

Adverse Events

Ampion 4 mL Dose

Serious events: 16 serious events

Other events: 154 other events

Deaths: 1 deaths

Placebo 4 mL Dose

Serious events: 11 serious events

Other events: 162 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Howard Levy / Chief Medical Officer

Ampio Pharmaceuticals

Phone: 7204376500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ampion 4 mL Dose n=520 participants at risk 4 mL Injection of Ampion	Placebo 4 mL Dose n=523 participants at risk 4 mL Injection of Placebo
Musculoskeletal and connective tissue disorders Arthralgia	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.19% 1/523 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.38% 2/520 • Number of events 2 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/520 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.19% 1/523 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Infections and infestations Cellulitis	0.38% 2/520 • Number of events 2 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Infections and infestations Diverticulitis	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Infections and infestations Gastroenteritis	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Infections and infestations Pneumonia	0.00% 0/520 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.19% 1/523 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/520 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.19% 1/523 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.38% 2/520 • Number of events 2 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.19% 1/523 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Vascular disorders Aortic aneurysm	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Vascular disorders Aortic dissection	0.00% 0/520 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.19% 1/523 • Number of events 2 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Vascular disorders Hypertensive urgency	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Metabolism and nutrition disorders Dehydration	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Metabolism and nutrition disorders Hypokalemia	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Cardiac disorders Angina pectoris	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Cardiac disorders Cardiac failure congestive	0.00% 0/520 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.19% 1/523 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/520 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.19% 1/523 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Gastrointestinal disorders Pancreatitis chronic	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
General disorders Chest pain	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
General disorders Incarcerated hernia	0.00% 0/520 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.19% 1/523 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Renal and urinary disorders Nephrolithiasis	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.00% 0/523 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Nervous system disorders Cerebrovascular accident	0.00% 0/520 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.19% 1/523 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Nervous system disorders Transient global amnesia	0.00% 0/520 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.19% 1/523 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Product Issues Device breakage	0.00% 0/520 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.19% 1/523 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.

Measure	Ampion 4 mL Dose n=520 participants at risk 4 mL Injection of Ampion	Placebo 4 mL Dose n=523 participants at risk 4 mL Injection of Placebo
Musculoskeletal and connective tissue disorders Arthralgia	5.8% 30/520 • Number of events 33 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	6.7% 35/523 • Number of events 41 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	1.5% 8/520 • Number of events 8 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	1.1% 6/523 • Number of events 6 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Musculoskeletal and connective tissue disorders Joint stiffness	1.5% 8/520 • Number of events 8 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	1.3% 7/523 • Number of events 8 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Musculoskeletal and connective tissue disorders Joint swelling	0.77% 4/520 • Number of events 4 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.96% 5/523 • Number of events 5 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.96% 5/520 • Number of events 5 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.96% 5/523 • Number of events 5 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	1.1% 6/523 • Number of events 6 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Nervous system disorders Dizziness	0.19% 1/520 • Number of events 1 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	1.1% 6/523 • Number of events 6 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Nervous system disorders Headache	0.96% 5/520 • Number of events 5 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.57% 3/523 • Number of events 3 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.77% 4/520 • Number of events 4 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.96% 5/523 • Number of events 5 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.96% 5/520 • Number of events 5 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.57% 3/523 • Number of events 4 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Vascular disorders Hypertension	1.3% 7/520 • Number of events 7 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.76% 4/523 • Number of events 4 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Gastrointestinal disorders Nausea	0.77% 4/520 • Number of events 4 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.96% 5/523 • Number of events 5 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
General disorders Injection site pain	0.96% 5/520 • Number of events 5 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.38% 2/523 • Number of events 2 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Infections and infestations Influenza	0.38% 2/520 • Number of events 2 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	1.1% 6/523 • Number of events 6 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Infections and infestations Nasopharyngitis	2.3% 12/520 • Number of events 12 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	2.3% 12/523 • Number of events 12 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Infections and infestations Sinusitis	3.5% 18/520 • Number of events 19 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	2.9% 15/523 • Number of events 18 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Infections and infestations Upper respiratory tract infection	2.7% 14/520 • Number of events 14 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	2.1% 11/523 • Number of events 11 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Infections and infestations Urinary tract infection	1.5% 8/520 • Number of events 8 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	2.1% 11/523 • Number of events 11 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Injury, poisoning and procedural complications Fall	0.96% 5/520 • Number of events 5 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	1.1% 6/523 • Number of events 6 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Infections and infestations Bronchitis	1.2% 6/520 • Number of events 6 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.76% 4/523 • Number of events 4 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.
Nervous system disorders Sciatica	0.38% 2/520 • Number of events 2 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.	0.96% 5/523 • Number of events 5 • 24 weeks Patients will be followed for the occurrence of Adverse Events (AEs) until 24 weeks after the first dose of study medication.