Trial Outcomes & Findings for Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence (NCT NCT02348112)

NCT ID: NCT02348112

Last Updated: 2023-12-04

Results Overview

Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.

Recruitment status

COMPLETED

Target enrollment

416 participants

Primary outcome timeframe

6 months

Results posted on

2023-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Altis Arm Subjects will have an Altis sling placed to treat stress urinary incontinence.	Comparator Arm Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.
Overall Study STARTED	213	203
Overall Study COMPLETED	140	101
Overall Study NOT COMPLETED	73	102

Reasons for withdrawal

Reasons for withdrawal
Measure	Altis Arm Subjects will have an Altis sling placed to treat stress urinary incontinence.	Comparator Arm Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.
Overall Study Withdrawal by Subject	32	29
Overall Study Lost to Follow-up	24	20
Overall Study Physician Decision	17	15
Overall Study Site closed due to PI leaving	0	30
Overall Study Sponsor withdrawal	0	7
Overall Study Death	0	1

Baseline Characteristics

2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Altis Arm n=213 Participants Subjects will have an Altis sling placed to treat stress urinary incontinence.	Comparator Arm n=203 Participants Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.	Total n=416 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=211 Participants • 2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.	0 Participants n=202 Participants • 2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.	0 Participants n=413 Participants • 2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.
Age, Categorical Between 18 and 65 years	153 Participants n=211 Participants • 2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.	155 Participants n=202 Participants • 2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.	308 Participants n=413 Participants • 2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.
Age, Categorical >=65 years	58 Participants n=211 Participants • 2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.	47 Participants n=202 Participants • 2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.	105 Participants n=413 Participants • 2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.
Age, Continuous	56.4 years STANDARD_DEVIATION 11.8 • n=211 Participants • 2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.	53.6 years STANDARD_DEVIATION 12.0 • n=202 Participants • 2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.	55.1 years STANDARD_DEVIATION 12.0 • n=413 Participants • 2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.
Sex: Female, Male Female	213 Participants n=213 Participants	203 Participants n=203 Participants	416 Participants n=416 Participants
Sex: Female, Male Male	0 Participants n=213 Participants	0 Participants n=203 Participants	0 Participants n=416 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	55 Participants n=213 Participants	25 Participants n=203 Participants	80 Participants n=416 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	156 Participants n=213 Participants	177 Participants n=203 Participants	333 Participants n=416 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=213 Participants	1 Participants n=203 Participants	3 Participants n=416 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=213 Participants	1 Participants n=203 Participants	1 Participants n=416 Participants
Race (NIH/OMB) Asian	0 Participants n=213 Participants	1 Participants n=203 Participants	1 Participants n=416 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=213 Participants	0 Participants n=203 Participants	0 Participants n=416 Participants
Race (NIH/OMB) Black or African American	3 Participants n=213 Participants	12 Participants n=203 Participants	15 Participants n=416 Participants
Race (NIH/OMB) White	205 Participants n=213 Participants	181 Participants n=203 Participants	386 Participants n=416 Participants
Race (NIH/OMB) More than one race	1 Participants n=213 Participants	3 Participants n=203 Participants	4 Participants n=416 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=213 Participants	5 Participants n=203 Participants	9 Participants n=416 Participants
Region of Enrollment United States	169 participants n=213 Participants	203 participants n=203 Participants	372 participants n=416 Participants
Region of Enrollment Canada	44 participants n=213 Participants	0 participants n=203 Participants	44 participants n=416 Participants
Pad Weight (g)	88.0 grams STANDARD_DEVIATION 155.8 • n=199 Participants • 14 participants in the Altis arm and 16 participants in the Comparator arm with pad weight test not done.	96.8 grams STANDARD_DEVIATION 154.7 • n=187 Participants • 14 participants in the Altis arm and 16 participants in the Comparator arm with pad weight test not done.	92.3 grams STANDARD_DEVIATION 155.1 • n=386 Participants • 14 participants in the Altis arm and 16 participants in the Comparator arm with pad weight test not done.

PRIMARY outcome

Timeframe: 6 months

Population: All enrolled subjects (Intent-to-Treat (ITT) analysis population) who have undergone a sling implant attempt for stress urinary incontinence using either Altis SIS or an FDA cleared transobturator or retropubic sling (modified Intent-to-Treat (mITT) analysis population). The mITT analysis population is a subset of the ITT population. The mITT analysis population is the primary analysis population for the assessment of all safety and effectiveness endpoints.

Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.

Outcome measures

Outcome measures
Measure	Altis Arm n=167 Participants Subjects will have an Altis sling placed to treat stress urinary incontinence.	Comparator Arm n=143 Participants Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.
Primary Effectiveness Endpoint	130 Participants	119 Participants

PRIMARY outcome

Timeframe: 36 months

Observed device and/or procedure-related serious adverse events through 36 months.

Outcome measures

Outcome measures
Measure	Altis Arm n=184 Participants Subjects will have an Altis sling placed to treat stress urinary incontinence.	Comparator Arm n=171 Participants Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.
Primary Safety Endpoint	2 Participants	4 Participants

Adverse Events

Altis Arm

Serious events: 24 serious events

Other events: 74 other events

Deaths: 0 deaths

Comparator Arm

Serious events: 29 serious events

Other events: 66 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Altis Arm n=184 participants at risk Subjects will have an Altis sling placed to treat stress urinary incontinence.	Comparator Arm n=171 participants at risk Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.
Renal and urinary disorders Urinary retention/obstruction	6.0% 11/184 • Number of events 11 • Adverse event data was collected through 36 months.	1.8% 3/171 • Number of events 3 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Hip pain	4.3% 8/184 • Number of events 8 • Adverse event data was collected through 36 months.	1.2% 2/171 • Number of events 2 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Pelvic / urogenital pain (groin)	5.4% 10/184 • Number of events 10 • Adverse event data was collected through 36 months.	2.9% 5/171 • Number of events 5 • Adverse event data was collected through 36 months.
Gastrointestinal disorders Nausea	2.7% 5/184 • Number of events 5 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Reproductive system and breast disorders Dyspareunia, de novo	8.7% 16/184 • Number of events 16 • Adverse event data was collected through 36 months.	2.9% 5/171 • Number of events 5 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Leg pain	2.2% 4/184 • Number of events 4 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Hip and leg pain	1.6% 3/184 • Number of events 3 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Renal and urinary disorders Recurrent incontinence	3.8% 7/184 • Number of events 7 • Adverse event data was collected through 36 months.	7.0% 12/171 • Number of events 12 • Adverse event data was collected through 36 months.
Reproductive system and breast disorders Dyspareunia, worsening	1.6% 3/184 • Number of events 3 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Renal and urinary disorders Urgency, worsening	1.1% 2/184 • Number of events 2 • Adverse event data was collected through 36 months.	8.2% 14/171 • Number of events 15 • Adverse event data was collected through 36 months.
Infections and infestations Infection	0.00% 0/184 • Adverse event data was collected through 36 months.	1.2% 2/171 • Number of events 2 • Adverse event data was collected through 36 months.
Renal and urinary disorders Urinary tract infection	21.2% 39/184 • Number of events 61 • Adverse event data was collected through 36 months.	22.8% 39/171 • Number of events 96 • Adverse event data was collected through 36 months.
Renal and urinary disorders Urgency, de novo	2.7% 5/184 • Number of events 5 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Reproductive system and breast disorders Vaginal discharge	1.6% 3/184 • Number of events 3 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.

Additional Information

Liz Driessen

Coloplast Corp.

Phone: 1-800-258-3476

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Altis Arm n=184 participants at risk Subjects will have an Altis sling placed to treat stress urinary incontinence.	Comparator Arm n=171 participants at risk Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.
Blood and lymphatic system disorders Bleeding, hematoma or hemorrhage	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Skin and subcutaneous tissue disorders Delayed wound healing	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Skin and subcutaneous tissue disorders Mesh exposure (extrusion)	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Respiratory, thoracic and mediastinal disorders Shortness of breath, chest pain, L jaw/neck pain	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Reproductive system and breast disorders Pelvic / urogenital pain (groin)	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Injury, poisoning and procedural complications Perforation, bladder	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Renal and urinary disorders Urinary retention/obstruction	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Infections and infestations Abdominal Abscess following appendectomy	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Endocrine disorders Acute pancreatitis	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Renal and urinary disorders Acute renal failure	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Reproductive system and breast disorders Adenomyosis	0.00% 0/184 • Adverse event data was collected through 36 months.	1.2% 2/171 • Number of events 2 • Adverse event data was collected through 36 months.
Gastrointestinal disorders Appendicitis	1.1% 2/184 • Number of events 2 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Broke left arm	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Broke right arm	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Broken left ankle	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Broken right ankle	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Cervical Spinal Stenosis	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Hepatobiliary disorders Cholelithiasis	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Gastrointestinal disorders Diverticular stenosis	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Elective surgery of total prosthesis right knee	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Respiratory, thoracic and mediastinal disorders Exacerbation of COPD	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 4 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Femur fracture	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Nervous system disorders Hydrocephalus	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Infections and infestations Intra-abdominal abscess	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Vascular disorders Left Carotid Stenosis	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Left Humerus Fracture	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic cancer	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
General disorders Morbid Obesity	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Cardiac disorders Non STEMI myocardial Infarction	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Infections and infestations Parastomal abscess and cellulitis	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Cardiac disorders Paroxysmal Atrial Fibrillation	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Gastrointestinal disorders Partial small bowel obstruction	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Patient hurt her shoulder	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Infections and infestations Perianal abscess	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Reproductive system and breast disorders Pre-Cancerous Cells Removed From Left Breast	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Gastrointestinal disorders Rectal Bleeding	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Cardiac disorders Retro-sternal pain	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Right Elbow fracture	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Right Shoulder Reconstructive Surgery	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Right bimalleolar ankle fracture, fibular fracture	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Right carpal tunnel release surgery	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Gastrointestinal disorders Small bowel obstruction and fistula	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Thoracic Degenerative Discs	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Total right knee prothesis	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Gastrointestinal disorders Vomiting	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Worsening Right knee pain	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Cardiac disorders Abnormal cardiac stress test	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Reproductive system and breast disorders Abnormal mammogram	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Bilateral knee pain	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Vascular disorders Deep vein thrombosis	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
General disorders Drug overdose	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Reproductive system and breast disorders Endometrial cancer	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Endocrine disorders Increased blood sugars	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Left femur fracture	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Medial meniscus tear of right knee	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
General disorders Ocular migraine	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Infections and infestations Pneumonia	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Respiratory, thoracic and mediastinal disorders Pulmonary thromboembolism	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Recurrent gluteus Medius tear	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Cardiac disorders Right coronary occlusion	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Right index finger and thumb injury	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Infections and infestations Sepsis	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Gastrointestinal disorders Small bowel obstruction	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Spinal cord stimulator	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Musculoskeletal and connective tissue disorders Total left knee prothesis	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.
Cardiac disorders Unstable angina / chest pains	0.00% 0/184 • Adverse event data was collected through 36 months.	0.58% 1/171 • Number of events 1 • Adverse event data was collected through 36 months.
Infections and infestations Wound necrosis	0.54% 1/184 • Number of events 1 • Adverse event data was collected through 36 months.	0.00% 0/171 • Adverse event data was collected through 36 months.