Trial Outcomes & Findings for Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial (NCT NCT02276885)
NCT ID: NCT02276885
Last Updated: 2025-12-30
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
284 participants
Primary outcome timeframe
60 months
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
PBI Radiotherapy 6 Gy
Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days
PBI Radiotherapy 6 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days
|
PBI Radiotherapy 8 Gy
Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
PBI Radiotherapy 8 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
140
|
|
Overall Study
COMPLETED
|
137
|
138
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
PBI Radiotherapy 6 Gy
Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days
PBI Radiotherapy 6 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days
|
PBI Radiotherapy 8 Gy
Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
PBI Radiotherapy 8 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
Baseline Characteristics
Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial
Baseline characteristics by cohort
| Measure |
PBI Radiotherapy 6 Gy
n=144 Participants
Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days
PBI Radiotherapy 6 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days
|
PBI Radiotherapy 8 Gy
n=140 Participants
Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
PBI Radiotherapy 8 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=174 Participants
|
9 Participants
n=166 Participants
|
19 Participants
n=167 Participants
|
|
Race (NIH/OMB)
White
|
110 Participants
n=174 Participants
|
109 Participants
n=166 Participants
|
219 Participants
n=167 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=174 Participants
|
18 Participants
n=166 Participants
|
33 Participants
n=167 Participants
|
|
Region of Enrollment
United States
|
144 participants
n=174 Participants
|
140 participants
n=166 Participants
|
284 participants
n=167 Participants
|
|
Age, Continuous
|
69 years
n=174 Participants
|
68 years
n=166 Participants
|
68 years
n=167 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=174 Participants
|
140 Participants
n=166 Participants
|
284 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=174 Participants
|
9 Participants
n=166 Participants
|
22 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=174 Participants
|
123 Participants
n=166 Participants
|
246 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=174 Participants
|
8 Participants
n=166 Participants
|
16 Participants
n=167 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=174 Participants
|
4 Participants
n=166 Participants
|
13 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
PRIMARY outcome
Timeframe: 60 monthsOutcome measures
| Measure |
PBI Radiotherapy 6 Gy
n=137 Participants
Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days
PBI Radiotherapy 6 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days
|
PBI Radiotherapy 8 Gy
n=138 Participants
Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
PBI Radiotherapy 8 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day
|
|---|---|---|
|
Percentage of Participants With Grade 2 or 3 Fibrosis
|
18.30 percentage of participants
|
12.30 percentage of participants
|
SECONDARY outcome
Timeframe: 1 year post randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year post randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 years post randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 years post randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years post randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years post randomizationOutcome measures
Outcome data not reported
Adverse Events
PBI Radiotherapy 6 Gy
Serious events: 0 serious events
Other events: 144 other events
Deaths: 4 deaths
PBI Radiotherapy 8 Gy
Serious events: 1 serious events
Other events: 140 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
PBI Radiotherapy 6 Gy
n=144 participants at risk
Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days
PBI Radiotherapy 6 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days
|
PBI Radiotherapy 8 Gy
n=140 participants at risk
Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
PBI Radiotherapy 8 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
Other adverse events
| Measure |
PBI Radiotherapy 6 Gy
n=144 participants at risk
Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days
PBI Radiotherapy 6 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days
|
PBI Radiotherapy 8 Gy
n=140 participants at risk
Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
PBI Radiotherapy 8 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day
|
|---|---|---|
|
Nervous system disorders
Aversion to Certain Foods
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Personage turner syndrome
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Mental Fogginess
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Sciatica
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Endocrine disorders
Diabetes
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Hepatobiliary disorders
Elevated AFP
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Eye disorders
Watering eyes
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
Diarrhea
|
2.8%
4/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Dizziness
|
2.1%
3/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
3.6%
5/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
3/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Infections and infestations
Urinary Tract Infection
|
2.1%
3/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.9%
4/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Investigations
Discomfort from table positioning
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
8/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
7.9%
11/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Renal and urinary disorders
Urinary Incontinence
|
3.5%
5/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Infections and infestations
Upper respiratory infection
|
4.9%
7/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Renal and urinary disorders
Urinary Frequency
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Superficial Soft TIssue Fibrosis
|
34.0%
49/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
32.1%
45/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
6.2%
9/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.9%
4/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Infections and infestations
skin infection
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Injury, poisoning and procedural complications
Seroma
|
8.3%
12/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
5.0%
7/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
8/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
General disorders
Edema limbs
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.1%
39/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
25.0%
35/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Immune system disorders
Elevated IgE
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Breast Asymmetry
|
12.5%
18/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
10.7%
15/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.9%
7/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
7.9%
11/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
Bloating
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Blood and lymphatic system disorders
Myelodysplastic syndrome
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Blood and lymphatic system disorders
Cervical Adenopathy
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Body odor
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast Atrophy
|
25.0%
36/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
29.3%
41/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Brain dx other - fogsy
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast disorder: tingling
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast disorder: twinges
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Infections and infestations
Breast infection
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Endocrine disorders
Hypercholesteremia
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast pain
|
25.0%
36/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
17.9%
25/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Injury, poisoning and procedural complications
Bruising
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Cardiac disorders
Palpitations
|
2.1%
3/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Cardiac disorders
Left coronary artery artherosclerotic dx
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
General disorders
Non-cardiac chest pain
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast retraction
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
Constipation
|
4.9%
7/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Concentration impairment
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Endocrine disorders
Cushingoid
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
70.1%
101/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
58.6%
82/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Investigations
Weight Loss
|
2.1%
3/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Psychiatric disorders
Depression
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
5.0%
7/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Investigations
Weight Gain
|
5.6%
8/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Psychiatric disorders
Agitation
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Immune system disorders
Allergic reaction
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
8/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.9%
4/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Amnesia
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Blood and lymphatic system disorders
Anemia
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Metabolism and nutrition disorders
Anorexia
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Psychiatric disorders
Anxiety
|
3.5%
5/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
7.9%
11/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.2%
6/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Infections and infestations
Wound infection
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Eye disorders
Redness
|
2.1%
3/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
7/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
6.4%
9/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.9%
7/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.9%
4/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
General disorders
Fatigue
|
76.4%
110/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
87.1%
122/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
Nausea
|
6.2%
9/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
3.6%
5/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.1%
3/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
6.4%
9/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.1%
3/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
5.7%
8/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
General disorders
Fever
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
General disorders
Flu like symptoms
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Injury, poisoning and procedural complications
Fracture
|
2.8%
4/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Paresthesia
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
5.0%
7/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
Abdominal Cramping
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
GI Symptoms
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
Diverticulosis
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Headache
|
4.2%
6/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
6.4%
9/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
telangiectasia
|
4.2%
6/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
syncope
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
nipple deformity
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
General disorders
non-cardiac chest pain
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
stomach pain
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Infections and infestations
Papulopustular rash
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
5.0%
7/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.8%
4/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.9%
4/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
joint range of motion decreased
|
2.1%
3/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
3.6%
5/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Vascular disorders
lymphedema
|
6.2%
9/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Psychiatric disorders
Insomnia
|
3.5%
5/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Eye disorders
periorbital edema
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
18/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
10.7%
15/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Vascular disorders
Hypertension
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Renal and urinary disorders
Hematuria
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
54.2%
78/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
47.9%
67/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Vascular disorders
Hot Flashes
|
44.4%
64/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
47.9%
67/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
General disorders
Pain
|
31.9%
46/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
30.7%
43/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Cardiac disorders
Heart failure
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Vascular disorders
Hematoma
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Skin Induration
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Infections and infestations
Giardia
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Hepatobiliary disorders
Hepatobiliary dx - Other: hepatic steatosis
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Hepatobiliary disorders
Hepatobiliary dx- Other: LFTs/increased/transiminitis
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Vascular disorders
Hypotension
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Infections and infestations
Cellulitis (Skin Infection)
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Infections and infestations
Osteomyelitis
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Infections and infestations
COVID 19
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
General disorders
localized edema
|
19.4%
28/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
18.6%
26/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Infections and infestations
Lyme disease
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Injury, poisoning and procedural complications
Pelvic prolapse
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Injury, poisoning and procedural complications
Right Inguinal Hernia
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Injury, poisoning and procedural complications
Knee sprain
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Injury, poisoning and procedural complications
Arm/Wrist Broken
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Injury, poisoning and procedural complications
L4-L5 Central and Lateral Stenosis
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast tenderness
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.1%
3/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Cardiac disorders
Irregular heart rhythm
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Psychiatric disorders
Irritability
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast abscess
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast dimpling
|
4.9%
7/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
5.0%
7/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
20.8%
30/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
21.4%
30/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast skin thickening
|
5.6%
8/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
4.3%
6/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast seborrheic keratosis
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Infections and infestations
Eye infection
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
2.8%
4/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Arm Tightness
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Hemiparesis
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Bursitis (Shoulder)
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Arm pain
|
2.1%
3/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Hand stiffness
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
LE Stiffness Intermittent
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Tissue Defect LLIQ with Arm Elevation
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Radiculitis
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Degenerative joint desease
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Alzheimer
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Imbalance
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Right Elbow Ulnar Nerve Entrapment
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Meningioma
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Balancing Issues
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Aphasia
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
amyloid angiopathy
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
erythrodysesthesia syndrome
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Psychiatric disorders
Mood changes
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Vascular disorders
Thromboembolic event
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Vascular disorders
Cold flashes
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast intertrigo candida
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Surgical and medical procedures
Breast Surgical Incision Drainage
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Breast burning sensation
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
2.9%
4/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Renal and urinary disorders
Papillary Urethelial Carcinoma
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Renal and urinary disorders
Intermittent increased urinary frequency post BCG treatment
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
vaginal spotting
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
vaginal atrophy
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Ovarian Mass/Fibroma
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Nipple Discharge
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast red/blue discoloration
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Cardiac disorders
Aortic Thrombosis
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
breast swelling
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
uterine fibroid
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
breast sx site hypersensation
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
1.4%
2/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Psychiatric disorders
Difficult Coping With Diagnosis
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Fibrocystic changes
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
shoulder discomfort due to positioning
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
LLQ of Left Breast
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Scar tissueat sx site
|
2.1%
3/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Skin breakdown (breast)
|
2.1%
3/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Pre-ulcerative Calluses Feet
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Hepatobiliary disorders
Hemangioma Right Hepatic
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Breast Eczema
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Breast Skin Reaction
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast LUQ Tissue Defect
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
1.4%
2/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Lip sore
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Facial Redness
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
fat necrosis
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Mouth Swelling
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Contraction at Surgical Site (braest)
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Papule/Folliculitis Breast Fold
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Neck Nodule
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Breast incision surgical defect
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
chest wall nodule
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
LIQ Breast Mass
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Pre-cancerous Skin Lesion
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Hand rash
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders: other - Tick bite
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Eye disorders
Cataract
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Respiratory, thoracic and mediastinal disorders
Ground glass opacity (GGO)
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other: Axilla pain
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other: Keloid
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other: Adhesive capsulitis
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.71%
1/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
|
Eye disorders
Blurred vision
|
0.69%
1/144 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
0.00%
0/140 • From the date that subjects signed the ICF until the 5 years follow up visit (EOS)
Clinical assessment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place