Trial Outcomes & Findings for Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer (NCT NCT05581589)
NCT ID: NCT05581589
Last Updated: 2026-04-27
Results Overview
Percentage of patients with no histologic evidence of tumor at time of cystectomy (ypT0N0)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
At radical cystectomy (Radical cystectomy is expected to occur within 2-6 weeks after the last neoadjuvant trial therapy dose)
Results posted on
2026-04-27
Participant Flow
Participant milestones
| Measure |
Treatment (Sacituzumab Govitecan)
Patients receive sacituzumab govitecan IV over 3 hours on days 1 and 8 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after last dose, patients undergo radical cystectomy and pelvic lymph node dissection.
Lymphadenectomy: Undergo pelvic lymph node dissection
Radical Cystectomy: Undergo radical cystectomy
Sacituzumab Govitecan: Given IV
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Sacituzumab Govitecan)
n=4 Participants
Patients receive sacituzumab govitecan IV over 3 hours on days 1 and 8 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after last dose, patients undergo radical cystectomy and pelvic lymph node dissection.
Lymphadenectomy: Undergo pelvic lymph node dissection
Radical Cystectomy: Undergo radical cystectomy
Sacituzumab Govitecan: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=226 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=226 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=226 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=226 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=226 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=226 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=226 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=226 Participants
|
PRIMARY outcome
Timeframe: At radical cystectomy (Radical cystectomy is expected to occur within 2-6 weeks after the last neoadjuvant trial therapy dose)Percentage of patients with no histologic evidence of tumor at time of cystectomy (ypT0N0)
Outcome measures
| Measure |
Treatment (Sacituzumab Govitecan)
n=4 Participants
Patients receive sacituzumab govitecan IV over 3 hours on days 1 and 8 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after last dose, patients undergo radical cystectomy and pelvic lymph node dissection.
Lymphadenectomy: Undergo pelvic lymph node dissection
Radical Cystectomy: Undergo radical cystectomy
Sacituzumab Govitecan: Given IV
|
|---|---|
|
Pathologic Complete Response (pCR Defined as ypT0N0)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years from time of study enrollmentPopulation: Only participants who were still on the trial and assessed for cancer recurrence and survival at the 2-year time point were included in this outcome analysis.
Measured as the percentage of participants who are cancer recurrence-free at 2 years
Outcome measures
| Measure |
Treatment (Sacituzumab Govitecan)
n=3 Participants
Patients receive sacituzumab govitecan IV over 3 hours on days 1 and 8 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after last dose, patients undergo radical cystectomy and pelvic lymph node dissection.
Lymphadenectomy: Undergo pelvic lymph node dissection
Radical Cystectomy: Undergo radical cystectomy
Sacituzumab Govitecan: Given IV
|
|---|---|
|
Recurrence-free Survival at the 2-year Time Point
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years from time of study enrollmentMeasured as the percentage of participants who are alive at 2 years
Outcome measures
| Measure |
Treatment (Sacituzumab Govitecan)
n=3 Participants
Patients receive sacituzumab govitecan IV over 3 hours on days 1 and 8 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after last dose, patients undergo radical cystectomy and pelvic lymph node dissection.
Lymphadenectomy: Undergo pelvic lymph node dissection
Radical Cystectomy: Undergo radical cystectomy
Sacituzumab Govitecan: Given IV
|
|---|---|
|
Overall Survival (OS) at the 2-year Time Point
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years from time of study enrollmentThe frequency of toxicity of study therapy regimen. Measured as the number of participants who experienced an AE (any grade) related to study therapy while on trial.
Outcome measures
| Measure |
Treatment (Sacituzumab Govitecan)
n=4 Participants
Patients receive sacituzumab govitecan IV over 3 hours on days 1 and 8 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after last dose, patients undergo radical cystectomy and pelvic lymph node dissection.
Lymphadenectomy: Undergo pelvic lymph node dissection
Radical Cystectomy: Undergo radical cystectomy
Sacituzumab Govitecan: Given IV
|
|---|---|
|
Frequency of Any Adverse Event According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) Related to Study Therapy.
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years from time of study enrollmentThe severity of toxicity of therapy regimen. Measured as the number of participants who experienced an AE of grade 3 or higher related to study therapy while on trial
Outcome measures
| Measure |
Treatment (Sacituzumab Govitecan)
n=4 Participants
Patients receive sacituzumab govitecan IV over 3 hours on days 1 and 8 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after last dose, patients undergo radical cystectomy and pelvic lymph node dissection.
Lymphadenectomy: Undergo pelvic lymph node dissection
Radical Cystectomy: Undergo radical cystectomy
Sacituzumab Govitecan: Given IV
|
|---|---|
|
Frequency of Grade 3 or Greater Adverse Events According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) Related to Study Therapy.
|
3 Participants
|
SECONDARY outcome
Timeframe: At radical cystectomy (radical cystectomy occured within 6 weeks after the last neoadjuvant trial therapy dose)To assess the percentage of patients who had pathologic downstaging to \<ypT2N0 stage at time of radical cystectomy
Outcome measures
| Measure |
Treatment (Sacituzumab Govitecan)
n=4 Participants
Patients receive sacituzumab govitecan IV over 3 hours on days 1 and 8 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after last dose, patients undergo radical cystectomy and pelvic lymph node dissection.
Lymphadenectomy: Undergo pelvic lymph node dissection
Radical Cystectomy: Undergo radical cystectomy
Sacituzumab Govitecan: Given IV
|
|---|---|
|
Pathologic Downstaging to <ypT2N0 at Time of Radical Cystectomy
|
1 Participants
|
Adverse Events
Treatment (Sacituzumab Govitecan)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Sacituzumab Govitecan)
n=4 participants at risk
Patients receive sacituzumab govitecan IV over 3 hours on days 1 and 8 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after last dose, patients undergo radical cystectomy and pelvic lymph node dissection.
Lymphadenectomy: Undergo pelvic lymph node dissection
Radical Cystectomy: Undergo radical cystectomy
Sacituzumab Govitecan: Given IV
|
|---|---|
|
Renal and urinary disorders
Acute Renal Failure
|
25.0%
1/4 • Number of events 4 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
Other adverse events
| Measure |
Treatment (Sacituzumab Govitecan)
n=4 participants at risk
Patients receive sacituzumab govitecan IV over 3 hours on days 1 and 8 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after last dose, patients undergo radical cystectomy and pelvic lymph node dissection.
Lymphadenectomy: Undergo pelvic lymph node dissection
Radical Cystectomy: Undergo radical cystectomy
Sacituzumab Govitecan: Given IV
|
|---|---|
|
Investigations
Neutrophil Count Decreased
|
100.0%
4/4 • Number of events 6 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Investigations
Aspartate Aminotransferase Increased
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Investigations
Alanine Aminotransferase Increased
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Investigations
Alkaline Phosphatase Increased
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
3/4 • Number of events 5 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Investigations
White Blood Cell Decreased
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 2 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
General disorders
Fatigue
|
100.0%
4/4 • Number of events 4 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
75.0%
3/4 • Number of events 3 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 3 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 2 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
General disorders
Flu Like Symptoms
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Infections and infestations
Lung Infection
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
2/4 • Number of events 2 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
General disorders
Chest Pain
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Gastrointestinal disorders
Abdominal Fullness
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
General disorders
Right Jaw Pain
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Investigations
Platelet Count Decreased
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 2 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
1/4 • Number of events 2 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Investigations
Creatinine Increased
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Investigations
Lymphocyte Count Decreased
|
25.0%
1/4 • Number of events 2 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Nervous system disorders
Dysguesia
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • Number of events 1 • Other (excluding serious) adverse events (AE) were monitored from trial therapy initiation up to 30 days after last day of trial drug administration or initiation of alternate therapy (up to 3 months total) Serious AE were monitored from the time of trial therapy initiation up to 90 days after the last day of trial drug administration (up to 5 months total) Recurrence-free survival and overall survival (all-cause mortality) were monitored for up to 2 years from time of trial enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place