Trial Outcomes & Findings for SCHEDULE Follow Up Visit 5-7 yr (NCT NCT02864706)

Last Updated: 2019-10-03

Results Overview

Renal function as assessed by measured Glomerular Filtration Rate (mGFR) (Cr-EDTA or iohexol clearance). Baseline Visit 1 and Patient 4252 excluded from the intent treat analysis set.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

95 participants

Primary outcome timeframe

at the 5-7 year follow-up visit

Results posted on

2019-10-03

Participant Flow

In total, 95 patients (48 everolimus, 47 controls), attended the follow-up visit at 5-7 years post-transplant and were included in the safety population The PP population (27 everolimus, 35 controls) excluded 7 patients in the everolimus group and 11 in the control group who discontinued study drug prematurely

Two patients randomized to everolimus did not provide a month 12 measured GFR (mGFR) value and were excluded from the ITT population, which thus comprised 93 patients (46 everolimus, 47 controls).

Participant milestones

Participant milestones
Measure	Everolimus patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks	Control patients received standard CsA, MMF and corticosteroids
Overall Study STARTED	48	47
Overall Study Safety Set	48	47
Overall Study Intent to Treat	46	47
Overall Study COMPLETED	48	47
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Everolimus n=48 Participants patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks	Control n=47 Participants patients received standard CsA, MMF and corticosteroids	Total n=95 Participants Total of all reporting groups
Age, Continuous	50.13 Years STANDARD_DEVIATION 13.43 • n=5 Participants	52.11 Years STANDARD_DEVIATION 11.61 • n=7 Participants	51.11 Years STANDARD_DEVIATION 12.53 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants • Safety Set	12 Participants n=7 Participants • Safety Set	25 Participants n=5 Participants • Safety Set
Sex: Female, Male Male	35 Participants n=5 Participants • Safety Set	35 Participants n=7 Participants • Safety Set	70 Participants n=5 Participants • Safety Set
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	44 Participants n=7 Participants	91 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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

PRIMARY outcome

Timeframe: at the 5-7 year follow-up visit

Population: intent to treat. 1 patient was excluded from ITT due to missing mGFR.

Renal function as assessed by measured Glomerular Filtration Rate (mGFR) (Cr-EDTA or iohexol clearance). Baseline Visit 1 and Patient 4252 excluded from the intent treat analysis set.

Outcome measures

Outcome measures
Measure	Everolimus n=45 Participants patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks	Control n=46 Participants patients received standard CsA, MMF and corticosteroids
Measured Glomerular Filtration Rate (mGFR)	74.7 mL/min/1.73m2 Standard Deviation 23.3	62.4 mL/min/1.73m2 Standard Deviation 16.5

SECONDARY outcome

Timeframe: within 5-7 years

Population: Intent to Treat.

Cardiac Allograft Vasculopathy (CAV) was defined as mean maximal intimal thickness (MIT) ≥0.5 mm, measured for the entire matched pullback recording by intravascular ultrasound (IVUS). The incidence of CAV at 5-7 years was compared between groups using the Cochran-Mantel-Haenszel test with stratification according to baseline distribution of CAV incidence.

Outcome measures

Outcome measures
Measure	Everolimus n=36 Participants patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks	Control n=35 Participants patients received standard CsA, MMF and corticosteroids
Progression of Cardiac Allograft Vasculopathy (CAV) Recorded by Intravascular Ultrasound (IVUS)	0.13 mm Standard Deviation 0.15	0.23 mm Standard Deviation 0.24

SECONDARY outcome

Timeframe: at the 5-7 year follow-up

Population: Intent to Treat

Outcome measures

Outcome measures
Measure	Everolimus n=36 Participants patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks	Control n=35 Participants patients received standard CsA, MMF and corticosteroids
Percent of Participants With Incidence of Coronary Allograft Vasculopathy (CAV)	53 percent of participants	74 percent of participants

SECONDARY outcome

Timeframe: within 5-7 years

Population: intent to treat

Myocardial structure and function by echocardiography assessment measured by ventricular end systolic diameter.

Outcome measures

Outcome measures
Measure	Everolimus n=46 Participants patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks	Control n=47 Participants patients received standard CsA, MMF and corticosteroids
Myocardial Structure and Function LVESD (left ventricular end systolic diameter)	3.1 cm Standard Deviation 0.8	3.1 cm Standard Deviation 0.6
Myocardial Structure and Function LVEDD (left ventricular end diastolic diameter)	4.7 cm Standard Deviation 0.6	4.9 cm Standard Deviation 0.6

SECONDARY outcome

Timeframe: at the 5-7 year visit

Population: intent to treat

This Quality of life Short Form Survey with 36 items (Minnesota Living with Heart Failure Questionnaire)was administered to patients pre-transplantation and after transplantation at the 5-7 year visit. This data represents the change. The survey consist of scores on a scale. Each form is scaled from 0 t 100. 0 = maximum disability and 100 equals no disability.

Outcome measures

Outcome measures
Measure	Everolimus n=46 Participants patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks	Control n=47 Participants patients received standard CsA, MMF and corticosteroids
Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up Bodily Pain	10.3 scores on a scale Standard Deviation 34.8	7.2 scores on a scale Standard Deviation 34.1
Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up Physical Health Summary	16.8 scores on a scale Standard Deviation 15.0	13.2 scores on a scale Standard Deviation 13.3
Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up Mental Health Summary	10.4 scores on a scale Standard Deviation 10.5	15.3 scores on a scale Standard Deviation 15.5
Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up Physical Functioning	36.7 scores on a scale Standard Deviation 38.4	40.8 scores on a scale Standard Deviation 30.4
Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up Role Physical	50.2 scores on a scale Standard Deviation 32.3	55.1 scores on a scale Standard Deviation 32.4
Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up General Health	25.7 scores on a scale Standard Deviation 26.4	23.4 scores on a scale Standard Deviation 25.6
Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up Vitality	30.0 scores on a scale Standard Deviation 25.8	28.9 scores on a scale Standard Deviation 29.0
Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up Social Functioning	39.9 scores on a scale Standard Deviation 31.5	43.9 scores on a scale Standard Deviation 32.4
Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up Role Emotional	23.8 scores on a scale Standard Deviation 36.7	42.8 scores on a scale Standard Deviation 46.5
Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up Mental Health	8.6 scores on a scale Standard Deviation 17.2	14.4 scores on a scale Standard Deviation 25.8

SECONDARY outcome

Timeframe: Baseline, 5-7 year visit

Population: intent to treat

Change from baseline in Euro Quality of Life-5D from 3 Year Follow-Up to 5 to 7 Year Follow-Up Baseline Visit 1 (ITT Set) Euro Quality of Life 5D (EQ-5D): is a descriptive system of healthrelated quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each of which can be assessed as one of three levels of severity (no problems/some or moderate problems/extreme problems). A Visual Analogue Scale (VAS)-scale is also included in the EQ-5D questionnaire. The EQ-5D index is calculated based on the United Kingdom Time Trade-Off (TTO) N3 value set which converts the five dimensions scores into a single measure with a possible range from -0.163 (worst possible health state) to +1 (perfect health). A positive change from baseline indicates an improvement in Quality of Life.

Outcome measures

Outcome measures
Measure	Everolimus n=46 Participants patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks	Control n=46 Participants patients received standard CsA, MMF and corticosteroids
Change From Baseline in the Euro Quality of Life 5D	0.2323 scores on the scale Standard Deviation 0.3849	0.2982 scores on the scale Standard Deviation 0.3274

SECONDARY outcome

Timeframe: baseline, at the 5-7 year visit

Population: Intent to treat

Change in visual analog scale (VAS) from baseline to the 5 to 7 Year follow up visit. 0 is no pain; and 10 is the worst possible pain

Outcome measures

Outcome measures
Measure	Everolimus n=46 Participants patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks	Control n=47 Participants patients received standard CsA, MMF and corticosteroids
Change From Baseline in Visual Analog Scale (VAS)	35.6 mm Standard Deviation 26.9	34.0 mm Standard Deviation 32.0

SECONDARY outcome

Timeframe: at the 5-7 year visit

Population: ITT

Beck Depression Inventory (BDI) Score has the following categories of depression. Normal, Mild, Moderate Severe and Missing.

Outcome measures

Outcome measures
Measure	Everolimus n=46 Participants patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks	Control n=47 Participants patients received standard CsA, MMF and corticosteroids
Number of Participants With Beck Depression Inventory (BDI) Normal	15 Participants	13 Participants
Number of Participants With Beck Depression Inventory (BDI) Mild	6 Participants	4 Participants
Number of Participants With Beck Depression Inventory (BDI) Moderate	2 Participants	5 Participants
Number of Participants With Beck Depression Inventory (BDI) Severe	1 Participants	0 Participants
Number of Participants With Beck Depression Inventory (BDI) Missing	3 Participants	5 Participants

Adverse Events

Everolimus

Serious events: 26 serious events

Other events: 15 other events

Deaths: 0 deaths

Control

Serious events: 18 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Everolimus n=48 participants at risk All participants who were included in the initial core study SCHEDULE (CRAD001ANO02) who received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.	Control n=47 participants at risk patients received standard CsA, MMF and corticosteroids
Gastrointestinal disorders Diarrhoea	8.3% 4/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	6.4% 3/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
General disorders Oedema peripheral	10.4% 5/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Infections and infestations Pneumonia	16.7% 8/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	4.3% 2/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Infections and infestations Sepsis	6.2% 3/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)

Additional Information

Clinical Disclosure Office

Novartis Pharmaceuticals

Phone: (862) 778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Everolimus n=48 participants at risk All participants who were included in the initial core study SCHEDULE (CRAD001ANO02) who received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.	Control n=47 participants at risk patients received standard CsA, MMF and corticosteroids
Respiratory, thoracic and mediastinal disorders Pneumonia	27.1% 13/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	6.4% 3/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Cardiac disorders Acute myocardial infarction	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Cardiac disorders Arrhythmia	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Cardiac disorders Atrial fibrillation	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Cardiac disorders Atrioventricular block	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Cardiac disorders Cardiac arrest	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Cardiac disorders Cardiac failure	4.2% 2/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Cardiac disorders Stress cardiomyopathy	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Eye disorders Retinal detachment	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Gastrointestinal disorders Anal fissure	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Gastrointestinal disorders Diarrhoea	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	4.3% 2/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Gastrointestinal disorders Food poisoning	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Gastrointestinal disorders Large intestinal stenosis	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Gastrointestinal disorders Proctalgia	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Gastrointestinal disorders Small intestinal perforation	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
General disorders Hernia	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
General disorders Oedema peripheral	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Hepatobiliary disorders Cholelithiasis	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Immune system disorders Heart transplant rejection	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Infections and infestations Diverticulitis	4.2% 2/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Infections and infestations Escherichia sepsis	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Infections and infestations Gastroenteritis	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Infections and infestations Herpes zoster	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Infections and infestations Meningitis	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Infections and infestations Pneumonia	27.1% 13/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	6.4% 3/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Infections and infestations Sepsis	4.2% 2/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Infections and infestations Upper respiratory tract infection	4.2% 2/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	4.3% 2/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Infections and infestations Urinary tract infection	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Infections and infestations Viral infection	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Injury, poisoning and procedural complications Femoral neck fracture	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Injury, poisoning and procedural complications Femur fracture	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Injury, poisoning and procedural complications Pelvic fracture	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Musculoskeletal and connective tissue disorders Back pain	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	4.3% 2/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Nervous system disorders Cerebrovascular accident	0.00% 0/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	2.1% 1/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Nervous system disorders Syncope	4.2% 2/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Psychiatric disorders Depression	4.2% 2/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)
Vascular disorders Aortic aneurysm	2.1% 1/48 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)	0.00% 0/47 • An average of 3 years (from the 3 year follow-up visit to the 5-7 year follow-up visit)