Trial Outcomes & Findings for Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study (NCT NCT04398368)
NCT ID: NCT04398368
Last Updated: 2023-08-08
Results Overview
Number of participants without recurrence of Urothelial Carcinoma. Relapse-free survival will be assessed by cystoscopy and urine cytology.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2023-08-08
Participant Flow
Participant milestones
| Measure |
Prevention (Gemcitabine Hydrochloride)
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
Gemcitabine Hydrochloride: Given intravesically
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Prevention (Gemcitabine Hydrochloride)
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
Gemcitabine Hydrochloride: Given intravesically
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prevention (Gemcitabine Hydrochloride)
n=25 Participants
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
Gemcitabine Hydrochloride: Given intravesically
|
|---|---|
|
Age, Continuous
|
72.38 years
STANDARD_DEVIATION 8.84 • n=25 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearNumber of participants without recurrence of Urothelial Carcinoma. Relapse-free survival will be assessed by cystoscopy and urine cytology.
Outcome measures
| Measure |
Prevention (Gemcitabine Hydrochloride)
n=23 Participants
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
Gemcitabine Hydrochloride: Given intravesically
|
|---|---|
|
Urothelial Carcinoma Relapse-free Survival
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearNumber of days from Radical Nephroureterectomy to date of histologic proof of recurrence/relapse of Urothelial Carcinoma
Outcome measures
| Measure |
Prevention (Gemcitabine Hydrochloride)
n=23 Participants
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
Gemcitabine Hydrochloride: Given intravesically
|
|---|---|
|
Time to Recurrence
|
178.75 Days
Standard Deviation 136.39
|
SECONDARY outcome
Timeframe: Up to 2 yearsAdverse events will be categorized by grade and further distinguished as serious adverse events. Furthermore, they will be designated by each site as not related, unlikely, possible, probably, and definitely related to treatment adverse events. they will also be summarized and organized by organ system, with the number and percent of patients experiencing the adverse event at least once and the number of patients exposed. Adverse events will be described and analyzed qualitatively. Adverse events will be grouped into categories and numerically described.
Outcome measures
| Measure |
Prevention (Gemcitabine Hydrochloride)
n=23 Participants
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
Gemcitabine Hydrochloride: Given intravesically
|
|---|---|
|
Incidence of Adverse Events
|
213 Adverse Events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsNumber of subject to experience muscle-invasive bladder cancer. Assessed by Urothelial Carcinoma on final pathology of Transurethral Resection of Bladder Tumor specimen or Urothelial Carcinoma on final pathology of radical cystectomy specimen.
Outcome measures
| Measure |
Prevention (Gemcitabine Hydrochloride)
n=23 Participants
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
Gemcitabine Hydrochloride: Given intravesically
|
|---|---|
|
Incidence of Muscle-invasive Bladder Cancer
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsDefined as the time (days) from date of Radical Nephroureterectomy to date of histologic proof of Urothelial Carcinoma
Outcome measures
| Measure |
Prevention (Gemcitabine Hydrochloride)
n=23 Participants
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
Gemcitabine Hydrochloride: Given intravesically
|
|---|---|
|
Time to Development of Muscle-invasive Bladder Cancer
|
178.75 Days
Standard Deviation 136.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsDefined as the time (days) from date of Radical Nephroureterectomy to date of death
Outcome measures
| Measure |
Prevention (Gemcitabine Hydrochloride)
n=23 Participants
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
Gemcitabine Hydrochloride: Given intravesically
|
|---|---|
|
Time to Death
|
543 Days
Standard Deviation 379.97
|
Adverse Events
Prevention (Gemcitabine Hydrochloride)
Serious events: 4 serious events
Other events: 19 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Prevention (Gemcitabine Hydrochloride)
n=25 participants at risk
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
Gemcitabine Hydrochloride: Given intravesically
|
|---|---|
|
Cardiac disorders
atrioventricular block (complete)
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Cancer recurrence
|
16.0%
4/25 • Number of events 4 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Gastrointestinal disorders
Nectrotic segment of small intestine
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
Other adverse events
| Measure |
Prevention (Gemcitabine Hydrochloride)
n=25 participants at risk
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
Gemcitabine Hydrochloride: Given intravesically
|
|---|---|
|
Gastrointestinal disorders
abdominal pain
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Hemmorrhage
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Hematuria
|
12.0%
3/25 • Number of events 7 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Ear and labyrinth disorders
Hearing Impared
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Sore Throat
|
8.0%
2/25 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Facial Flushing
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Cardiac disorders
Chest Pain
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Gastrointestinal disorders
Nausea
|
24.0%
6/25 • Number of events 9 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Nervous system disorders
Dizziness
|
12.0%
3/25 • Number of events 4 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Nocturia
|
16.0%
4/25 • Number of events 6 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Infections and infestations
Urinary Tract Infection
|
20.0%
5/25 • Number of events 8 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Nervous system disorders
Hot Flashes
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Flank Pain
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
16.0%
4/25 • Number of events 6 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Gastrointestinal disorders
Bloating
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Penile Pain
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Infections and infestations
Scrotal Infection
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Perineal pain
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Bladder Pain
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Reproductive system and breast disorders
Testicular Pain
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Phantom Pain
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Gastrointestinal disorders
Constipation
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
16.0%
4/25 • Number of events 5 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Vascular disorders
Leg Edema
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Immune system disorders
Fever
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Metabolism and nutrition disorders
Loss of Appetite
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Nervous system disorders
Lightheadedness
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Nervous system disorders
Weakness/Fatigue
|
28.0%
7/25 • Number of events 8 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Metallic taste
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Bladder Leak
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Hyperkalemia
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Anemia
|
8.0%
2/25 • Number of events 5 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Nervous system disorders
Insomnia
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Scalp pain
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Metabolism and nutrition disorders
Weight gain
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Hypertension
|
20.0%
5/25 • Number of events 6 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Musculoskeletal and connective tissue disorders
Scrotal Bruising
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Reproductive system and breast disorders
Penile cancer
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Gross hematuria
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Urinary retention
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Cardiac disorders
Tachycardia
|
4.0%
1/25 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Hepatobiliary disorders
Abnormal liver function lab values
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Anxiety
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Low platelet count
|
16.0%
4/25 • Number of events 7 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Elevated creatinine
|
20.0%
5/25 • Number of events 8 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Headaches
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Urinary urgency
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Increased urinary frequency
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Nervous system disorders
Hypotension
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic aorta calcification
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Eye disorders
Decreased vision function, unilateral
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Eye disorders
Dry eye syndrome, bilateral
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Bladder Spasm
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Subcutaneous emphysema
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Hyperlipidemia
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Fall (loss of balance)
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumoperitoneum
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Metabolism and nutrition disorders
Weight loss
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Elevated white blood call count
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Gastrointestinal disorders
Unable to pass gas
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Musculoskeletal and connective tissue disorders
Fissure, foot
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Gastrointestinal disorders
Polyp, colon
|
8.0%
2/25 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Vivasilar interstitial opacities
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Gastrointestinal disorders
Hernia
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Musculoskeletal and connective tissue disorders
Rotation of right foot
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Ear and labyrinth disorders
Complete hearing loss
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Ear and labyrinth disorders
Ear infection
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Elevated alkaline phosphatase
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Infections and infestations
Peritonitis
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Nervous system disorders
Facial numbness
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Increased red blood cell distribution width
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Elevated platelet count
|
8.0%
2/25 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Psychiatric disorders
Depression
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Incontinence
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Nervous system disorders
Neuropathy
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Elevated Blood urea nitrogen
|
4.0%
1/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Low hematocrit
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Low erythrocytes
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
increased alanine aminotransferase (ALT)
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Musculoskeletal and connective tissue disorders
Degenerative arthritis
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Eye disorders
Ptosis, unilateral
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Eye disorders
Cataract, unilateral
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Atypical urothelial cells in urine
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Blood and lymphatic system disorders
Low Chloride
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Renal and urinary disorders
Clear cell cystic renal cell cancer
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
Infections and infestations
Ehrlichiosis
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
|
General disorders
Oral dysesthia
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place