Trial Outcomes & Findings for Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder (NCT NCT02621151)
NCT ID: NCT02621151
Last Updated: 2025-10-07
Results Overview
Bladder-intact disease-free survival is defined as the time from initiation of protocol therapy until the first occurrence of muscle-invasive bladder cancer recurrence, regional pelvic recurrence, distant metastases, bladder cancer-related death, or cystectomy.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
2 years
Results posted on
2025-10-07
Participant Flow
Participant milestones
| Measure |
Pembrolizumab, Gemcitabine, and RT
* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV)
* Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic)
* External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy)
* Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT
* Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT
Pembrolizumab
Transurethral Resection of Bladder Tumor
Gemcitabine
External Beam Radiation Therapy
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Pembrolizumab, Gemcitabine, and RT
* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV)
* Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic)
* External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy)
* Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT
* Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT
Pembrolizumab
Transurethral Resection of Bladder Tumor
Gemcitabine
External Beam Radiation Therapy
|
|---|---|
|
Overall Study
Not eligible for trial
|
6
|
Baseline Characteristics
Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder
Baseline characteristics by cohort
| Measure |
Pembrolizumab, Gemcitabine, and RT
n=54 Participants
* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV)
* Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic)
* External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy)
* Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT
* Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT
Pembrolizumab
Transurethral Resection of Bladder Tumor
Gemcitabine
External Beam Radiation Therapy
|
|---|---|
|
Age, Continuous
|
73.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The analysis focused on the efficacy cohort and did not include the safety lead-in cohort.
Bladder-intact disease-free survival is defined as the time from initiation of protocol therapy until the first occurrence of muscle-invasive bladder cancer recurrence, regional pelvic recurrence, distant metastases, bladder cancer-related death, or cystectomy.
Outcome measures
| Measure |
Pembrolizumab, Gemcitabine, and RT
n=48 Participants
* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV)
* Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic)
* External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy)
* Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT
* Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT
Pembrolizumab
Transurethral Resection of Bladder Tumor
Gemcitabine
External Beam Radiation Therapy
|
|---|---|
|
Percentage of Participants Who Achieved Two-year Bladder-intact Disease-free Survival
|
60 percentage of participants
Interval 45.0 to 73.0
|
SECONDARY outcome
Timeframe: up to 21 weeksPopulation: The analysis focused on the efficacy cohort and did not include the safety lead-in cohort.
The CR rate is the percentage of patients who have achieved CR. At the completion of protocol therapy, patients undergo standard cystoscopy, exam under anesthesia and transurethral resection of bladder tumor to document pathologic response. CR requires no tumor palpable on bimanual examination under anesthesia, no tumor visible on cystoscopy, negative tumor site biopsy, and negative urine cytology.
Outcome measures
| Measure |
Pembrolizumab, Gemcitabine, and RT
n=48 Participants
* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV)
* Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic)
* External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy)
* Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT
* Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT
Pembrolizumab
Transurethral Resection of Bladder Tumor
Gemcitabine
External Beam Radiation Therapy
|
|---|---|
|
Complete Response (CR) Rate
|
56 percentage of participants
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: The analysis focused on the efficacy cohort and did not include the safety lead-in cohort.
Outcome measures
| Measure |
Pembrolizumab, Gemcitabine, and RT
n=48 Participants
* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV)
* Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic)
* External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy)
* Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT
* Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT
Pembrolizumab
Transurethral Resection of Bladder Tumor
Gemcitabine
External Beam Radiation Therapy
|
|---|---|
|
Percentage of Participants Who Survived at Study Completion
|
83 percentage of participants
Interval 68.9 to 91.1
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: The analysis focused on the efficacy cohort and did not include the safety lead-in cohort.
Metastasis-free survival is defined as not having developed radiographic distant metastases.
Outcome measures
| Measure |
Pembrolizumab, Gemcitabine, and RT
n=48 Participants
* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV)
* Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic)
* External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy)
* Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT
* Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT
Pembrolizumab
Transurethral Resection of Bladder Tumor
Gemcitabine
External Beam Radiation Therapy
|
|---|---|
|
Percentage of Participants Who Achieved Metastasis-free Survival at Study Completion
|
84 percentage of participants
Interval 70.0 to 92.0
|
Adverse Events
Pembrolizumab, Gemcitabine, and RT
Serious events: 15 serious events
Other events: 54 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Pembrolizumab, Gemcitabine, and RT
n=54 participants at risk
* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV)
* Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic)
* External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy)
* Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT
* Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT
Pembrolizumab
Transurethral Resection of Bladder Tumor
Gemcitabine
External Beam Radiation Therapy
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
24.1%
13/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Investigations
Aspartate Aminotransferase Increased
|
16.7%
9/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.3%
5/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Cardiac disorders
Chest Pain
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Colitis
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Colonic Perforation
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
General disorders
Death
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Protein Losing Enteropathy
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Hematuria
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
6/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Immune system disorders
Immune System Disorders - Other
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemotherapy
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) - Other
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Infections and infestations
Upper Respiratory Infection
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Urinary Tract Infection
|
24.1%
13/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
Other adverse events
| Measure |
Pembrolizumab, Gemcitabine, and RT
n=54 participants at risk
* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV)
* Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic)
* External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy)
* Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT
* Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT
Pembrolizumab
Transurethral Resection of Bladder Tumor
Gemcitabine
External Beam Radiation Therapy
|
|---|---|
|
Gastrointestinal disorders
Abdominal Distention
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Investigations
Alanine Aminotransferace Increased
|
16.7%
9/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
18/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Anorexia
|
27.8%
15/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Psychiatric disorders
Anxiety
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
9.3%
5/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
General disorders
Edema limbs
|
16.7%
9/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Bladder Spasm
|
20.4%
11/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Bloating
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Investigations
Blood Bilirubin Increased
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Infection
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Injury, poisoning and procedural complications
Bruising
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Cardiac disorders
Cardiac Disorders - Other
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
General disorders
Chills
|
9.3%
5/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
General disorders
Cold
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Constipation
|
22.2%
12/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
6/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Investigations
Creatinine Increase
|
11.1%
6/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Cystitis Noninfective
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Psychiatric disorders
Delirium
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Diarrhea
|
46.3%
25/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Nervous system disorders
Dizziness
|
13.0%
7/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Dry Mouth
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Nervous system disorders
Dysgeusia
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.3%
5/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Dysuria
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Ear and labyrinth disorders
Otitis Media
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Ear and labyrinth disorders
Ear And Labyrinth Disorders - Other
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Investigations
Elevated Lft
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
General disorders
Fatigue
|
57.4%
31/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Fecal Incontinence
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
General disorders
Fever
|
14.8%
8/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Flatulence
|
7.4%
4/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
General disorders
Flu Like Symptoms
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
General disorders
Gait Disturbance
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Gas
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
18.5%
10/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
General disorders
General Disorders And Administration Site Conditions - Other
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
7.4%
4/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Fecal Urgency
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Diverticulosis
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Loose Stool
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Nervous system disorders
Headache
|
13.0%
7/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Hematuria
|
31.5%
17/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.3%
5/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Cardiac disorders
Hypertension
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Endocrine disorders
Hyperthyroidism
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
7.4%
4/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.3%
5/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Cardiac disorders
Hypotension
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Endocrine disorders
Hypothyroidism
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Infections and infestations
Kidney Infection
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Infections and infestations
Infection - Other
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Psychiatric disorders
Insomnia
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Injury, poisoning and procedural complications
Intraoperative Urinary Injury
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Blood and lymphatic system disorders
Iron Deficiency Anemia
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
General disorders
Irritability
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Lower Abdominal Discomfort
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Reproductive system and breast disorders
Pelvic Pain
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decreased
|
7.4%
4/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
General disorders
Malaise
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders, Other
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Infections and infestations
Musocal Infection
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Upper Limb
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Nausea
|
50.0%
27/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.8%
8/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
General disorders
Pain
|
14.8%
8/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Nervous system disorders
Paresthesia
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Investigations
Platelet Count Decreased
|
29.6%
16/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Nervous system disorders
Presyncope
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Proctitis
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Proteinuria
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
6/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.9%
14/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Rectal Mucus Discharge
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Rectal Pain
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Rectal Spasms
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Rectal Ulcer
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Rectal Urgency
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Renal And Urinary Disorders - Other
|
11.1%
6/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Eye disorders
Retinopathy
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Cardiac disorders
Sinus Bradycardia
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Cardiac disorders
Sinus Tachycardia
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Skin and subcutaneous tissue disorders
Skin And Other Subcutaneous Tissue Disorders - Other
|
5.6%
3/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.7%
2/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Stomach Pain
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Cardiac disorders
Supraventricular Tachycardia
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Vascular disorders
Thromboembolitic Event
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Infections and infestations
Tooth Infection
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Urinary Frequency
|
38.9%
21/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Urinary Incontinence
|
14.8%
8/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Urinary Retention
|
7.4%
4/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Urinary Tract Pain
|
35.2%
19/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Renal and urinary disorders
Urinary Urgency
|
14.8%
8/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Vascular disorders
Vascular Disorder, Other
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
9/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Investigations
Weight Gain
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Blood and lymphatic system disorders
White Blood Cell Decreased
|
14.8%
8/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.9%
1/54 • AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
investigator assessment at each treatment and follow-up visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place