Trial Outcomes & Findings for Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy (NCT NCT00776594)
NCT ID: NCT00776594
Last Updated: 2016-10-21
Results Overview
To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
2 years
Results posted on
2016-10-21
Participant Flow
Participant milestones
| Measure |
Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
|
Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
36
|
|
Overall Study
COMPLETED
|
62
|
34
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Baseline characteristics by cohort
| Measure |
Androgen Deprivation Therapy Plus Bevacizumab
n=66 Participants
Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
|
Androgen Deprivation Therapy Alone
n=36 Participants
Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=99 Participants
|
63 years
n=107 Participants
|
65 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.
Outcome measures
| Measure |
Group 1
n=66 Participants
Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
|
Group 2
n=36 Participants
Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
|
|---|---|---|
|
Relapse-free Survival
|
13 months
Interval 11.0 to 15.0
|
10 months
Interval 10.0 to 12.0
|
SECONDARY outcome
Timeframe: Six months (at completion of treatment)Number of participants with a PSA \<0.2 ng/ml at six months (upon completion of treatment).
Outcome measures
| Measure |
Group 1
n=64 Participants
Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
|
Group 2
n=35 Participants
Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
|
|---|---|---|
|
Number of Participants With PSA <0.2 ng/ml at Six Months
|
51 Number of participants
|
27 Number of participants
|
SECONDARY outcome
Timeframe: 6 monthsThe number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.
Outcome measures
| Measure |
Group 1
n=65 Participants
Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
|
Group 2
n=36 Participants
Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
|
|---|---|---|
|
Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).
|
48 participants
|
13 participants
|
SECONDARY outcome
Timeframe: 6 monthsAnalysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).
Outcome measures
| Measure |
Group 1
n=43 Participants
Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
|
Group 2
n=21 Participants
Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
|
|---|---|---|
|
Analysis of Cytokines and Angiogenic Factors in Plasma/Serum
|
13755 pg/ml
Interval 6570.0 to 25762.0
|
10179 pg/ml
Interval 6924.0 to 15333.0
|
Adverse Events
Group 2
Serious events: 5 serious events
Other events: 32 other events
Deaths: 0 deaths
Group 1
Serious events: 18 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 2
n=36 participants at risk
Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
|
Group 1
n=66 participants at risk
Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
|
|---|---|---|
|
Cardiac disorders
Cardiac-ischemia
|
0.00%
0/36
|
1.5%
1/66
|
|
Vascular disorders
Hypertension
|
5.6%
2/36
|
19.7%
13/66
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/36
|
1.5%
1/66
|
|
Infections and infestations
Infection w/ unk ANC peritoneal cavity
|
0.00%
0/36
|
1.5%
1/66
|
|
Infections and infestations
Infection w/ unk ANC ungual (nails)
|
0.00%
0/36
|
1.5%
1/66
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/36
|
1.5%
1/66
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/36
|
1.5%
1/66
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
2.8%
1/36
|
1.5%
1/66
|
|
Nervous system disorders
Syncope
|
2.8%
1/36
|
1.5%
1/66
|
|
Nervous system disorders
Head/headache
|
0.00%
0/36
|
1.5%
1/66
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm- wheezing
|
0.00%
0/36
|
1.5%
1/66
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.8%
1/36
|
0.00%
0/66
|
Other adverse events
| Measure |
Group 2
n=36 participants at risk
Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
|
Group 1
n=66 participants at risk
Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/36
|
6.1%
4/66
|
|
Immune system disorders
Allergy-other
|
0.00%
0/36
|
1.5%
1/66
|
|
Blood and lymphatic system disorders
Bone marrow cellularity
|
0.00%
0/36
|
1.5%
1/66
|
|
Blood and lymphatic system disorders
Hemoglobin
|
8.3%
3/36
|
4.5%
3/66
|
|
Investigations
Leukocytes
|
2.8%
1/36
|
0.00%
0/66
|
|
Investigations
Lymphopenia
|
0.00%
0/36
|
3.0%
2/66
|
|
Investigations
Platelets
|
0.00%
0/36
|
4.5%
3/66
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/36
|
1.5%
1/66
|
|
Cardiac disorders
Arrhythmia-other
|
0.00%
0/36
|
1.5%
1/66
|
|
Vascular disorders
Hypertension
|
0.00%
0/36
|
28.8%
19/66
|
|
General disorders
Fatigue
|
22.2%
8/36
|
57.6%
38/66
|
|
General disorders
Fever w/o neutropenia
|
0.00%
0/36
|
3.0%
2/66
|
|
Psychiatric disorders
Insomnia
|
2.8%
1/36
|
10.6%
7/66
|
|
General disorders
Rigors/chills
|
0.00%
0/36
|
1.5%
1/66
|
|
Skin and subcutaneous tissue disorders
Sweating
|
5.6%
2/36
|
4.5%
3/66
|
|
Investigations
Weight gain
|
2.8%
1/36
|
0.00%
0/66
|
|
Investigations
Weight loss
|
0.00%
0/36
|
3.0%
2/66
|
|
General disorders
Constitutional- other
|
0.00%
0/36
|
4.5%
3/66
|
|
Injury, poisoning and procedural complications
Bruising
|
2.8%
1/36
|
1.5%
1/66
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/36
|
9.1%
6/66
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.8%
1/36
|
1.5%
1/66
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/36
|
1.5%
1/66
|
|
General disorders
Injection site reaction
|
0.00%
0/36
|
4.5%
3/66
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/36
|
3.0%
2/66
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.8%
1/36
|
3.0%
2/66
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/36
|
1.5%
1/66
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
2.8%
1/36
|
7.6%
5/66
|
|
Vascular disorders
Hot flashes
|
69.4%
25/36
|
63.6%
42/66
|
|
Endocrine disorders
Hyopthyroidism
|
0.00%
0/36
|
1.5%
1/66
|
|
Endocrine disorders
Endocrine-other
|
0.00%
0/36
|
1.5%
1/66
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/36
|
4.5%
3/66
|
|
Gastrointestinal disorders
Constipation
|
2.8%
1/36
|
13.6%
9/66
|
|
Gastrointestinal disorders
Dentures or dental prosthesis
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
2.8%
1/36
|
7.6%
5/66
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Fistula- Anus
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Incontinence- anal
|
2.8%
1/36
|
1.5%
1/66
|
|
Respiratory, thoracic and mediastinal disorders
Muco/stomatitis by exam- larynx
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Muco/stomatitis by exam- oral cavity
|
0.00%
0/36
|
3.0%
2/66
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
0.00%
0/36
|
3.0%
2/66
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) stomach
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36
|
3.0%
2/66
|
|
Gastrointestinal disorders
Salivary
|
0.00%
0/36
|
1.5%
1/66
|
|
Nervous system disorders
Taste disturbance
|
0.00%
0/36
|
3.0%
2/66
|
|
Gastrointestinal disorders
Ulcer- duodenum
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
GI-other
|
2.8%
1/36
|
3.0%
2/66
|
|
Gastrointestinal disorders
Lower GI- hemorrhage NOS
|
5.6%
2/36
|
3.0%
2/66
|
|
Gastrointestinal disorders
Oral cavity- hemorrhage
|
0.00%
0/36
|
6.1%
4/66
|
|
Gastrointestinal disorders
Rectum- hemorrhage
|
0.00%
0/36
|
1.5%
1/66
|
|
Renal and urinary disorders
Bladder- hemorrhage
|
0.00%
0/36
|
1.5%
1/66
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
2.8%
1/36
|
3.0%
2/66
|
|
Respiratory, thoracic and mediastinal disorders
Nose- hemorrhage
|
2.8%
1/36
|
22.7%
15/66
|
|
Vascular disorders
Hemorrhage-other
|
0.00%
0/36
|
1.5%
1/66
|
|
Infections and infestations
Infection Gr0-2 neut- bronchus
|
0.00%
0/36
|
1.5%
1/66
|
|
Infections and infestations
Infection Gr0-2 neut- oral cavity
|
0.00%
0/36
|
1.5%
1/66
|
|
Infections and infestations
Infection Gr0-2 neut- sinus
|
0.00%
0/36
|
3.0%
2/66
|
|
Infections and infestations
Infection Gr0-2 neut- upper airway
|
0.00%
0/36
|
1.5%
1/66
|
|
Infections and infestations
Infection Gr0-2 neut- urinary tract
|
0.00%
0/36
|
1.5%
1/66
|
|
Infections and infestations
Infection w/ unk ANC oral cavity/gums
|
0.00%
0/36
|
1.5%
1/66
|
|
Infections and infestations
Infection w/ unk ANC sinus
|
0.00%
0/36
|
1.5%
1/66
|
|
Infections and infestations
Infection w/ unk ANC urinary tract NOS
|
0.00%
0/36
|
1.5%
1/66
|
|
Infections and infestations
Infection-other
|
0.00%
0/36
|
3.0%
2/66
|
|
General disorders
Edema head and neck
|
0.00%
0/36
|
1.5%
1/66
|
|
General disorders
Edema limb
|
5.6%
2/36
|
6.1%
4/66
|
|
Blood and lymphatic system disorders
Lymphatics-other
|
0.00%
0/36
|
1.5%
1/66
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.8%
1/36
|
0.00%
0/66
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/36
|
1.5%
1/66
|
|
Investigations
ALT- SGPT
|
5.6%
2/36
|
6.1%
4/66
|
|
Investigations
AST- SGOT
|
5.6%
2/36
|
7.6%
5/66
|
|
Investigations
Bilirubin
|
0.00%
0/36
|
1.5%
1/66
|
|
Investigations
Hypercholesterolemia
|
2.8%
1/36
|
6.1%
4/66
|
|
Investigations
Creatinine
|
0.00%
0/36
|
9.1%
6/66
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/36
|
3.0%
2/66
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/36
|
1.5%
1/66
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/36
|
4.5%
3/66
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/36
|
3.0%
2/66
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/36
|
10.6%
7/66
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/36
|
3.0%
2/66
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.8%
1/36
|
7.6%
5/66
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/36
|
6.1%
4/66
|
|
General disorders
Extremity-lower (gait/walking)
|
2.8%
1/36
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Extremity upper (function)
|
0.00%
0/36
|
1.5%
1/66
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
0.00%
0/36
|
3.0%
2/66
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
0.00%
0/36
|
1.5%
1/66
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic upper extr muscle weak
|
0.00%
0/36
|
1.5%
1/66
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
2.8%
1/36
|
3.0%
2/66
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
2.8%
1/36
|
1.5%
1/66
|
|
Nervous system disorders
Ataxia
|
0.00%
0/36
|
1.5%
1/66
|
|
Nervous system disorders
Cognitive disturbance
|
2.8%
1/36
|
3.0%
2/66
|
|
Psychiatric disorders
Confusion
|
0.00%
0/36
|
1.5%
1/66
|
|
Nervous system disorders
Dizziness
|
5.6%
2/36
|
7.6%
5/66
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/36
|
1.5%
1/66
|
|
Psychiatric disorders
Agitation
|
0.00%
0/36
|
3.0%
2/66
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/36
|
1.5%
1/66
|
|
Psychiatric disorders
Depression
|
2.8%
1/36
|
3.0%
2/66
|
|
Eye disorders
Neuropathy CN II vision
|
0.00%
0/36
|
1.5%
1/66
|
|
Nervous system disorders
Neuropathy CN IX pharynx ear tongue
|
0.00%
0/36
|
1.5%
1/66
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/36
|
16.7%
11/66
|
|
Nervous system disorders
Neurologic-other
|
0.00%
0/36
|
3.0%
2/66
|
|
Eye disorders
Glaucoma
|
2.8%
1/36
|
0.00%
0/66
|
|
Eye disorders
Vision-blurred
|
0.00%
0/36
|
1.5%
1/66
|
|
Eye disorders
Ocular-other
|
2.8%
1/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Abdomen- pain
|
0.00%
0/36
|
3.0%
2/66
|
|
Gastrointestinal disorders
Anus- pain
|
0.00%
0/36
|
1.5%
1/66
|
|
Musculoskeletal and connective tissue disorders
Back- pain
|
5.6%
2/36
|
7.6%
5/66
|
|
Musculoskeletal and connective tissue disorders
Buttock- pain
|
0.00%
0/36
|
1.5%
1/66
|
|
Musculoskeletal and connective tissue disorders
Chest wall- pain
|
0.00%
0/36
|
3.0%
2/66
|
|
General disorders
Chest/thoracic pain NOS
|
0.00%
0/36
|
3.0%
2/66
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb- pain
|
2.8%
1/36
|
13.6%
9/66
|
|
Nervous system disorders
Head/headache
|
5.6%
2/36
|
42.4%
28/66
|
|
Musculoskeletal and connective tissue disorders
Joint- pain
|
5.6%
2/36
|
22.7%
15/66
|
|
Musculoskeletal and connective tissue disorders
Muscle- pain
|
0.00%
0/36
|
9.1%
6/66
|
|
Musculoskeletal and connective tissue disorders
Neck- pain
|
0.00%
0/36
|
3.0%
2/66
|
|
Nervous system disorders
Neuropathic- pain
|
0.00%
0/36
|
1.5%
1/66
|
|
Gastrointestinal disorders
Oral cavity- pain
|
0.00%
0/36
|
1.5%
1/66
|
|
Skin and subcutaneous tissue disorders
Scalp- pain
|
0.00%
0/36
|
1.5%
1/66
|
|
Reproductive system and breast disorders
Scrotum- pain
|
0.00%
0/36
|
1.5%
1/66
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx- pain
|
0.00%
0/36
|
1.5%
1/66
|
|
General disorders
Pain-other
|
0.00%
0/36
|
9.1%
6/66
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
1/36
|
7.6%
5/66
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/36
|
3.0%
2/66
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
2.8%
1/36
|
1.5%
1/66
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction- airway-bronchus
|
0.00%
0/36
|
1.5%
1/66
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
0.00%
0/36
|
15.2%
10/66
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
0.00%
0/36
|
7.6%
5/66
|
|
Renal and urinary disorders
Incontinence urinary
|
2.8%
1/36
|
4.5%
3/66
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
11.1%
4/36
|
22.7%
15/66
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/36
|
1.5%
1/66
|
|
Renal and urinary disorders
Renal/GU-other
|
2.8%
1/36
|
3.0%
2/66
|
|
Injury, poisoning and procedural complications
Intra-op injury Face NOS
|
0.00%
0/36
|
1.5%
1/66
|
|
Reproductive system and breast disorders
Erectile impotence
|
0.00%
0/36
|
1.5%
1/66
|
|
Psychiatric disorders
Libido
|
2.8%
1/36
|
0.00%
0/66
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place