Trial Outcomes & Findings for Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing (NCT NCT03558087)
NCT ID: NCT03558087
Last Updated: 2024-06-27
Results Overview
Clinical complete response rate will be defined as the percentage of patients who achieved cT0 or cTa disease after gemcitabine, cisplatin, plus nivolumab.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
24 months
Results posted on
2024-06-27
Participant Flow
Participant milestones
| Measure |
Gemcitabine, Cisplatin and Nivolumab
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.
Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine: Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin: Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.
|
|---|---|
|
Overall Study
STARTED
|
76
|
|
Overall Study
COMPLETED
|
76
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing
Baseline characteristics by cohort
| Measure |
Gemcitabine, Cisplatin and Nivolumab
n=76 Participants
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.
Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine: Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin: Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
|
Clinical stage
cT2N0M0
|
43 Participants
n=5 Participants
|
|
Clinical stage
cT3N0M0
|
24 Participants
n=5 Participants
|
|
Clinical stage
cT4N0M0
|
9 Participants
n=5 Participants
|
|
Histology
Urothelial Cancer (UC)
|
57 Participants
n=5 Participants
|
|
Histology
UC with squamous
|
7 Participants
n=5 Participants
|
|
Histology
UC with glandular
|
2 Participants
n=5 Participants
|
|
Histology
UC with micropapillary
|
6 Participants
n=5 Participants
|
|
Histology
UC with other variant
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsClinical complete response rate will be defined as the percentage of patients who achieved cT0 or cTa disease after gemcitabine, cisplatin, plus nivolumab.
Outcome measures
| Measure |
Gemcitabine, Cisplatin and Nivolumab
n=76 Participants
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.
Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine: Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin: Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.
|
|---|---|
|
Clinical Complete Response (CCR) Rate
|
43 Percentage of participants
Interval 32.0 to 55.0
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Among the 33 patients achieving a CCR, only one opted for immediate cystectomy with surgical pathology, revealing a low-grade ypTaN0 urothelial cancer (UC). Therefore 32 patients were used for this outcome measure.
Determine the ability of clinical complete response (cT0 or cTa) to predict benefit from treatment.Benefit will be defined as a pathologic complete response (\<pT1) in patients undergoing cystectomy and 2 year metastasis-free in patients pursuing surveillance. The positive predictive value of CCR with 95% confidence interval are presented in Outcome Measure Data Table. Positive predictive value is the ratio of patients truly diagnosed as positive to all those who had positive test results.
Outcome measures
| Measure |
Gemcitabine, Cisplatin and Nivolumab
n=32 Participants
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.
Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine: Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin: Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.
|
|---|---|
|
Predict Benefit From Treatment
|
0.97 Proportion of CCR patients
Interval 0.91 to 1.0
|
SECONDARY outcome
Timeframe: AE had been recorded from time of signed informed consent until 100 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.The frequency and severity of all grade 3+ treatment-emergent adverse events occurring in at least 10% of patients are reported by CTCAEv4 term and grade.
Outcome measures
| Measure |
Gemcitabine, Cisplatin and Nivolumab
n=76 Participants
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.
Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine: Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin: Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.
|
|---|---|
|
Adverse Events
ANEMIA
|
12 participants
|
|
Adverse Events
NEUTROPHIL COUNT DECREASED
|
26 participants
|
|
Adverse Events
URINARY TRACT INFECTION
|
13 participants
|
|
Adverse Events
HYPONATREMIA
|
5 participants
|
|
Adverse Events
HYPERTENSION
|
4 participants
|
|
Adverse Events
WHITE BLOOD CELL DECREASED
|
3 participants
|
|
Adverse Events
PLATELET COUNT DECREASED
|
4 participants
|
|
Adverse Events
HEMATURIA
|
3 participants
|
|
Adverse Events
DYSPNEA
|
1 participants
|
|
Adverse Events
VOMITING
|
1 participants
|
|
Adverse Events
ABDOMINAL PAIN
|
2 participants
|
|
Adverse Events
HYPOKALEMIA
|
3 participants
|
|
Adverse Events
PAIN
|
1 participants
|
|
Adverse Events
ASPARTATE AMINOTRANSFERASE INCREASED
|
1 participants
|
|
Adverse Events
DEPRESSION
|
1 participants
|
|
Adverse Events
ANXIETY
|
1 participants
|
|
Adverse Events
HYPERGLYCEMIA
|
2 participants
|
SECONDARY outcome
Timeframe: Up to a maximum of 60 monthsPopulation: Bladder-intact overall survival results are showing in accordance with CCR status. Out of 76 patients, 33 patients achieved a clinical complete response, and 43 patients did not achieve a clinical complete response.
Bladder-intact overall survival is defined as the time from initiation of treatment until death or cystectomy.
Outcome measures
| Measure |
Gemcitabine, Cisplatin and Nivolumab
n=76 Participants
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.
Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine: Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin: Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.
|
|---|---|
|
Bladder Intact Overall Survival
CCR Patients
|
NA Months
Interval 47.34 to
Not enough events occur to calculate the median and upper 95% confidence interval
|
|
Bladder Intact Overall Survival
Non-CCR Patients
|
4.53 Months
Interval 4.24 to 4.93
|
SECONDARY outcome
Timeframe: Up to a maximum of 60 monthsPopulation: Recurrence-free survival results are showing in accordance with CCR status. Out of 76 patients, 33 patients achieved a clinical complete response, and 43 patients did not achieve a clinical complete response.
Recurrence-free survival is defined as the time from initiation of treatment to death or recurrence, depending on which occurs first
Outcome measures
| Measure |
Gemcitabine, Cisplatin and Nivolumab
n=76 Participants
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.
Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine: Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin: Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.
|
|---|---|
|
Recurrence-free Survival
CCR Patients
|
51.52 Months
Interval 39.92 to
Not enough events occur to calculate the upper 95% confidence interval.
|
|
Recurrence-free Survival
Non-CCR Patients
|
NA Months
Interval 24.21 to
Not enough events occur to calculate the median and upper 95% confidence interval.
|
SECONDARY outcome
Timeframe: Up to a maximum of 53 monthsPopulation: Only 8 patients achieving a clinical complete response (CCR) later underwent cystectomy, and 34 patients not achieving a CCR underwent cystectomy.
Pathologic complete response rate in patients undergoing radical cystectomy is defined as the proportion of patients with \<pT1
Outcome measures
| Measure |
Gemcitabine, Cisplatin and Nivolumab
n=42 Participants
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.
Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine: Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin: Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.
|
|---|---|
|
Pathologic Complete Response Rate in Patients Undergoing Cystectomy
CCR Patients
|
1 Participants
|
|
Pathologic Complete Response Rate in Patients Undergoing Cystectomy
Non-CCR Patients
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 monthsBenefit will be defined as a pathologic complete response (p\<T1) in patients undergoing cystectomy and 2 years metastasis-free in patients pursuing surveillance. The positive predictive value of CCR with or without genomic alterations in baseline TURBT tissue for a composite outcome measure of 2-year bladder-intact survival in patients forgoing immediate cystectomy or \<ypT1N0 in patients undergoing immediate cystectomy are presented with 95% confidence interval in Outcome Measure Data Table. Positive predictive value is the ratio of patients truly diagnosed as positive to all those who had positive test results.
Outcome measures
| Measure |
Gemcitabine, Cisplatin and Nivolumab
n=33 Participants
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.
Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine: Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin: Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.
|
|---|---|
|
Association Between a Prespecified Panel of Genomic Biomarkers and Benefit From Treatment in Patients Achieving a Clinical Complete Response.
|
0.72 Proportion of CCR patients
Interval 0.56 to 0.87
|
SECONDARY outcome
Timeframe: Up to a maximum of 60 monthsPopulation: Overall survival results are showing in accordance with CCR status. Out of 76 patients, 33 patients achieved a clinical complete response, and 43 patients did not achieve a clinical complete response.
Overall survival is defined as the time from initiation of treatment to death.
Outcome measures
| Measure |
Gemcitabine, Cisplatin and Nivolumab
n=76 Participants
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.
Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine: Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin: Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.
|
|---|---|
|
Overall Survival
CCR Patients
|
NA Months
Not enough events occur to calculate the median and 95% confidence interval.
|
|
Overall Survival
Non-CCR Patients
|
NA Months
Interval 41.49 to
Not enough events occur to calculate the median and upper 95% confidence interval.
|
Adverse Events
Gemcitabine, Cisplatin and Nivolumab
Serious events: 40 serious events
Other events: 76 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Gemcitabine, Cisplatin and Nivolumab
n=76 participants at risk
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.
Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine: Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin: Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
6.6%
5/76 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Blood and lymphatic system disorders
ANEMIA
|
1.3%
1/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Psychiatric disorders
DEPRESSION
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
1.3%
1/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
FEVER
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
HEMATURIA
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
5.3%
4/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Vascular disorders
HYPOTENSION
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
3.9%
3/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
KIDNEY INFECTION
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
LUNG INFECTION
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS - OTHER, SPECIFY
|
2.6%
2/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
SEPSIS
|
5.3%
4/76 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
STROKE
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
3.9%
3/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
13.2%
10/76 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
VOMITING
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
Other adverse events
| Measure |
Gemcitabine, Cisplatin and Nivolumab
n=76 participants at risk
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.
Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine: Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin: Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.5%
8/76 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
3.9%
3/76 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
13.2%
10/76 • Number of events 17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
6.6%
5/76 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
26.3%
20/76 • Number of events 20 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Blood and lymphatic system disorders
ANEMIA
|
68.4%
52/76 • Number of events 146 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
28.9%
22/76 • Number of events 25 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Psychiatric disorders
ANXIETY
|
6.6%
5/76 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
11.8%
9/76 • Number of events 21 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
17.1%
13/76 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
BLOATING
|
3.9%
3/76 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY
|
21.1%
16/76 • Number of events 27 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
2.6%
2/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Eye disorders
BLURRED VISION
|
5.3%
4/76 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Injury, poisoning and procedural complications
BURN
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
CHILLS
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
CHOLESTEROL HIGH
|
5.3%
4/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
COGNITIVE DISTURBANCE
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
COLITIS
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
46.1%
35/76 • Number of events 38 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.9%
6/76 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
CREATININE INCREASED
|
47.4%
36/76 • Number of events 64 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
3.9%
3/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Psychiatric disorders
DEPRESSION
|
6.6%
5/76 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
14.5%
11/76 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
DIZZINESS
|
9.2%
7/76 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
DRY MOUTH
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
3.9%
3/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
DYSGEUSIA
|
11.8%
9/76 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
25.0%
19/76 • Number of events 24 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Ear and labyrinth disorders
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Ear and labyrinth disorders
EAR PAIN
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
EDEMA LIMBS
|
10.5%
8/76 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Endocrine disorders
ENDOCRINE DISORDERS - OTHER, SPECIFY
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
5.3%
4/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Eye disorders
EYE DISORDERS - OTHER, SPECIFY
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
FACIAL PAIN
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Injury, poisoning and procedural complications
FALL
|
3.9%
3/76 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
FATIGUE
|
71.1%
54/76 • Number of events 80 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
FEVER
|
5.3%
4/76 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Eye disorders
FLASHING LIGHTS
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
FLATULENCE
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
FLU LIKE SYMPTOMS
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Vascular disorders
FLUSHING
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
GAIT DISTURBANCE
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
3.9%
3/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
6.6%
5/76 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY
|
7.9%
6/76 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
3.9%
3/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
GGT INCREASED
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
HEADACHE
|
13.2%
10/76 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Vascular disorders
HEMATOMA
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
HEMATURIA
|
25.0%
19/76 • Number of events 26 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Hepatobiliary disorders
HEPATOBILIARY DISORDERS - OTHER, SPECIFY
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
2.6%
2/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
42.1%
32/76 • Number of events 57 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
10.5%
8/76 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Vascular disorders
HYPERTENSION
|
21.1%
16/76 • Number of events 28 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
3.9%
3/76 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDEMIA
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
3.9%
3/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
15.8%
12/76 • Number of events 18 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
14.5%
11/76 • Number of events 18 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
3.9%
3/76 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
15.8%
12/76 • Number of events 15 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
18.4%
14/76 • Number of events 29 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
26.3%
20/76 • Number of events 47 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
5.3%
4/76 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Vascular disorders
HYPOTENSION
|
3.9%
3/76 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
1.3%
1/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
ILEUS
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Immune system disorders
IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
3.9%
3/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
INFUSION RELATED REACTION
|
2.6%
2/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
INJECTION SITE REACTION
|
3.9%
3/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Psychiatric disorders
INSOMNIA
|
11.8%
9/76 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
INVESTIGATIONS - OTHER, SPECIFY
|
3.9%
3/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
KIDNEY INFECTION
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Cardiac disorders
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Psychiatric disorders
LIBIDO DECREASED
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
LIPASE INCREASED
|
6.6%
5/76 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
LOCALIZED EDEMA
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
5.3%
4/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Metabolism and nutrition disorders
METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY
|
9.2%
7/76 • Number of events 17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS UPPER LIMB
|
1.3%
1/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY
|
3.9%
3/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
3.9%
3/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
NAUSEA
|
56.6%
43/76 • Number of events 58 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
1.3%
1/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
NEURALGIA
|
1.3%
1/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
68.4%
52/76 • Number of events 151 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
ORAL PAIN
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
General disorders
PAIN
|
10.5%
8/76 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.3%
4/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Cardiac disorders
PALPITATIONS
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
PAPULOPUSTULAR RASH
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
PARESTHESIA
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Reproductive system and breast disorders
PERINEAL PAIN
|
1.3%
1/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Skin and subcutaneous tissue disorders
PERIORBITAL EDEMA
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
PERIORBITAL INFECTION
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
1.3%
1/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
7.9%
6/76 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Vascular disorders
PHLEBITIS
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
38.2%
29/76 • Number of events 59 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
PRESYNCOPE
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
PROTEINURIA
|
11.8%
9/76 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
14.5%
11/76 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Psychiatric disorders
PSYCHIATRIC DISORDERS - OTHER, SPECIFY
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
3.9%
3/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
17.1%
13/76 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS - OTHER, SPECIFY
|
23.7%
18/76 • Number of events 26 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
3.9%
3/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
SEPSIS
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Injury, poisoning and procedural complications
SEROMA
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
SERUM AMYLASE INCREASED
|
9.2%
7/76 • Number of events 15 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS DISORDER
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
SINUSITIS
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
13.2%
10/76 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
SOMNOLENCE
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
STOMA SITE INFECTION
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Vascular disorders
SUPERFICIAL THROMBOPHLEBITIS
|
3.9%
3/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Surgical and medical procedures
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
SYNCOPE
|
2.6%
2/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Ear and labyrinth disorders
TINNITUS
|
27.6%
21/76 • Number of events 22 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
TOOTHACHE
|
3.9%
3/76 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Nervous system disorders
TREMOR
|
5.3%
4/76 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
9.2%
7/76 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
2.6%
2/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
19.7%
15/76 • Number of events 29 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
10.5%
8/76 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Renal and urinary disorders
URINARY URGENCY
|
5.3%
4/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Injury, poisoning and procedural complications
UROSTOMY LEAK
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Vascular disorders
VASCULAR DISORDERS - OTHER, SPECIFY
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Ear and labyrinth disorders
VERTIGO
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Ear and labyrinth disorders
VESTIBULAR DISORDER
|
1.3%
1/76 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Gastrointestinal disorders
VOMITING
|
18.4%
14/76 • Number of events 19 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Eye disorders
WATERING EYES
|
1.3%
1/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
WEIGHT GAIN
|
2.6%
2/76 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
WEIGHT LOSS
|
13.2%
10/76 • Number of events 15 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
40.8%
31/76 • Number of events 65 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
|
Infections and infestations
WOUND INFECTION
|
1.3%
1/76 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place