Trial Outcomes & Findings for Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy (NCT NCT03725761)

Last Updated: 2025-05-13

Results Overview

Subjects who achieve ≥50% PSA decline at or before 9 weeks of therapy with Sacituzumab Govitecan (IMMU-132) are considered to have responded. PSA responses will be analyzed by descriptive statistics and summarized in tabular format (frequency tables). The overall PSA response rate will be reported along with the corresponding 95% confidence interval which will be constructed using the Wilson score method.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

up to 9 weeks

Results posted on

2025-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Sacituzumab Govitecan Treatment Participants enrolled in this study will receive Sacituzumab Govitecan in addition to their single agent Androgen Receptor Signaling Inhibitors (ARSI) as treatment for Castrate-Resistant Prostate Cancer. Dose will be calculated per protocol in milligrams based on the participant's body weight at the beginning of each cycle or more frequently if weight changes \>10%. Participants will be treated on days 1 and 8 in a 21-day cycle, minimum 3 cycles. Sacituzumab Govitecan is a novel Antibody Drug Conjugate (ADC) based on a humanized anti-Trop-2 antibody (hRS7) conjugated to SN-38 payload.
Overall Study STARTED	31
Overall Study Received Treatment	31
Overall Study Off Study Treatment Early	11
Overall Study Completed Treatment	19
Overall Study Currently on Treatment	1
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sacituzumab Govitecan Treatment Participants enrolled in this study will receive Sacituzumab Govitecan in addition to their single agent Androgen Receptor Signaling Inhibitors (ARSI) as treatment for Castrate-Resistant Prostate Cancer. Dose will be calculated per protocol in milligrams based on the participant's body weight at the beginning of each cycle or more frequently if weight changes \>10%. Participants will be treated on days 1 and 8 in a 21-day cycle, minimum 3 cycles. Sacituzumab Govitecan is a novel Antibody Drug Conjugate (ADC) based on a humanized anti-Trop-2 antibody (hRS7) conjugated to SN-38 payload.
Overall Study still on study	1

Baseline Characteristics

Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sacituzumab Govitecan Treatment n=31 Participants Participants enrolled in this study will receive Sacituzumab Govitecan in addition to their single agent ARSI as treatment for Castrate-Resistant Prostate Cancer. Dose will be calculated per protocol in milligrams based on the participant's body weight at the beginning of each cycle or more frequently if weight changes \>10%. Participants will be treated on days 1 and 8 in a 21-day cycle, minimum 3 cycles.
Age, Continuous	69 years STANDARD_DEVIATION 8.0 • n=5 Participants
Age, Customized 50-59 years	5 Participants n=5 Participants
Age, Customized 60-69 years	12 Participants n=5 Participants
Age, Customized 70-79 years	10 Participants n=5 Participants
Age, Customized 80-89 years	4 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	2 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants
Baseline Prostate Specific Antigen (PSA)	30 ng/ml n=5 Participants
History of Chemotherapy Chemo Naive	25 Participants n=5 Participants
History of Chemotherapy Chemo Exposed	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 9 weeks

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan Treatment n=31 Participants Participants enrolled in this study will receive Sacituzumab Govitecan in addition to their single agent ARSI as treatment for Castrate-Resistant Prostate Cancer. Dose will be calculated per protocol in milligrams based on the participant's body weight at the beginning of each cycle or more frequently if weight changes \>10%. Participants will be treated on days 1 and 8 in a 21-day cycle, minimum 3 cycles.	Grade 3 Grade 3 is a severe level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).	Grade 4 Grade 4 is a life-threatening level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).	Greater Than or Equal to 2 Grade 2 is a moderate level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).	Greater Than or Equal to 3 Grade 3 is a severe level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).	Greater Than or Equal to 4 Grade 4 is a life-threatening level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).
PSA Response Rate	6 percent Interval 2.0 to 21.0	—	—	—	—	—

PRIMARY outcome

Timeframe: 6 months

Proportion of participants remaining alive and progression free (using Prostate Cancer Working Group 2 (PCWG2) criteria) 6 months from time of starting treatment as estimated by the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan Treatment n=31 Participants Participants enrolled in this study will receive Sacituzumab Govitecan in addition to their single agent ARSI as treatment for Castrate-Resistant Prostate Cancer. Dose will be calculated per protocol in milligrams based on the participant's body weight at the beginning of each cycle or more frequently if weight changes \>10%. Participants will be treated on days 1 and 8 in a 21-day cycle, minimum 3 cycles.	Grade 3 Grade 3 is a severe level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).	Grade 4 Grade 4 is a life-threatening level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).	Greater Than or Equal to 2 Grade 2 is a moderate level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).	Greater Than or Equal to 3 Grade 3 is a severe level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).	Greater Than or Equal to 4 Grade 4 is a life-threatening level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).
6-Month Progression Free Survival Rate	52 percent	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years from start of treatment

The probability distribution of Progression Free Survival (PFS) will be estimated using the Kaplan-Meier method. The median will be estimated from this distribution. Subjects who have not died or progressed (using PCWG2 criteria) will be censored at the date of last assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 years from start of treatment

The number of participants with progressive disease, stable disease, partial response and complete response will be summarized in tabular format. The overall response rate will be reported along with the corresponding 95% confidence interval which will be constructed using the Wilson score method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years from start of treatment

Overall Survival (OS) is the duration from start of treatment until death from any cause. The probability distribution of OS will be estimated using the Kaplan-Meier method. The median will be estimated from this distribution. Subjects who have not died will be censored at the date of last contact.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 9 weeks from start of treatment

Toxicities will be summarized by type and severity in tabular format. Toxicity rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, etc.) will be calculated and reported along the corresponding 95% confidence intervals. The 95% confidence intervals will be constructed using the Wilson score method.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan Treatment n=73 number of adverse events Participants enrolled in this study will receive Sacituzumab Govitecan in addition to their single agent ARSI as treatment for Castrate-Resistant Prostate Cancer. Dose will be calculated per protocol in milligrams based on the participant's body weight at the beginning of each cycle or more frequently if weight changes \>10%. Participants will be treated on days 1 and 8 in a 21-day cycle, minimum 3 cycles.	Grade 3 n=31 number of adverse events Grade 3 is a severe level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).	Grade 4 n=11 number of adverse events Grade 4 is a life-threatening level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).	Greater Than or Equal to 2 n=115 number of adverse events Grade 2 is a moderate level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).	Greater Than or Equal to 3 n=42 number of adverse events Grade 3 is a severe level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).	Greater Than or Equal to 4 n=11 number of adverse events Grade 4 is a life-threatening level of toxicity per the Common Toxicity Criteria scale from Grade 0 (no toxicity) to Grade 5 (death).
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) White blood cell decreased	7 number of adverse events	2 number of adverse events	4 number of adverse events	13 number of adverse events	6 number of adverse events	4 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Syncope	0 number of adverse events	1 number of adverse events	0 number of adverse events	1 number of adverse events	1 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Typhlitis	0 number of adverse events	1 number of adverse events	0 number of adverse events	1 number of adverse events	1 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Vasovagal reaction	0 number of adverse events	1 number of adverse events	0 number of adverse events	1 number of adverse events	1 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Alopecia	10 number of adverse events	0 number of adverse events	0 number of adverse events	10 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Anemia	8 number of adverse events	4 number of adverse events	0 number of adverse events	12 number of adverse events	4 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Anorexia	4 number of adverse events	0 number of adverse events	0 number of adverse events	4 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Creatinine increased	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Dehydration	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Diarrhea	8 number of adverse events	7 number of adverse events	0 number of adverse events	15 number of adverse events	7 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Dysgeusia	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Dyspnea	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Fatigue	5 number of adverse events	0 number of adverse events	0 number of adverse events	5 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Febrile neutropenia	0 number of adverse events	2 number of adverse events	0 number of adverse events	2 number of adverse events	2 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Hyponatremia	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Hypophosphatemia	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Infusion site extravasation	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Intermittent body aches, general	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Mucositis oral	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Muscle weakness lower limb	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Nausea	5 number of adverse events	1 number of adverse events	0 number of adverse events	6 number of adverse events	1 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Neutrophil count decreased	9 number of adverse events	12 number of adverse events	7 number of adverse events	28 number of adverse events	19 number of adverse events	7 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Peripheral ischemia	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Platelet count decreased	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Rash maculo-papular	4 number of adverse events	0 number of adverse events	0 number of adverse events	4 number of adverse events	0 number of adverse events	0 number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.) Sinus tachycardia	1 number of adverse events	0 number of adverse events	0 number of adverse events	1 number of adverse events	0 number of adverse events	0 number of adverse events

Adverse Events

Sacituzumab Govitecan Treatment

Serious events: 12 serious events

Other events: 31 other events

Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure	Sacituzumab Govitecan Treatment n=31 participants at risk Participants enrolled in this study will receive Sacituzumab Govitecan in addition to their single agent ARSI as treatment for Castrate-Resistant Prostate Cancer. Dose will be calculated per protocol in milligrams based on the participant's body weight at the beginning of each cycle or more frequently if weight changes \>10%. Participants will be treated on days 1 and 8 in a 21-day cycle, minimum 3 cycles.
Nervous system disorders Spinal Cord Compression	9.7% 3/31 • up to 6 months
Infections and infestations Bladder Infection	3.2% 1/31 • up to 6 months
Gastrointestinal disorders Typhlitis	3.2% 1/31 • up to 6 months
Musculoskeletal and connective tissue disorders Back Pain	6.5% 2/31 • up to 6 months
Nervous system disorders Syncope	3.2% 1/31 • up to 6 months
Cardiac disorders Atrial Flutter	3.2% 1/31 • up to 6 months
Blood and lymphatic system disorders Febrile neutropenia	6.5% 2/31 • up to 6 months
Cardiac disorders Myocardial infarction	3.2% 1/31 • up to 6 months

Other adverse events

Other adverse events
Measure	Sacituzumab Govitecan Treatment n=31 participants at risk Participants enrolled in this study will receive Sacituzumab Govitecan in addition to their single agent ARSI as treatment for Castrate-Resistant Prostate Cancer. Dose will be calculated per protocol in milligrams based on the participant's body weight at the beginning of each cycle or more frequently if weight changes \>10%. Participants will be treated on days 1 and 8 in a 21-day cycle, minimum 3 cycles.
Blood and lymphatic system disorders Anemia	54.8% 17/31 • Number of events 31 • up to 6 months
Blood and lymphatic system disorders Febrile Neutropenia	3.2% 1/31 • Number of events 1 • up to 6 months
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	3.2% 1/31 • Number of events 1 • up to 6 months
Cardiac disorders Heart Failure	3.2% 1/31 • Number of events 1 • up to 6 months
Cardiac disorders Sinus Tachycardia	3.2% 1/31 • Number of events 1 • up to 6 months
Endocrine disorders Adrenal Insufficiency	3.2% 1/31 • Number of events 1 • up to 6 months
General disorders Chills	9.7% 3/31 • Number of events 3 • up to 6 months
General disorders Debility	3.2% 1/31 • Number of events 1 • up to 6 months
General disorders Edema Limbs	6.5% 2/31 • Number of events 2 • up to 6 months
General disorders Fatigue	41.9% 13/31 • Number of events 17 • up to 6 months
General disorders Fever	3.2% 1/31 • Number of events 1 • up to 6 months
General disorders Gait Disturbance	9.7% 3/31 • Number of events 3 • up to 6 months
General disorders Generalized Weakness	6.5% 2/31 • Number of events 2 • up to 6 months
General disorders Hernia	3.2% 1/31 • Number of events 1 • up to 6 months
General disorders Infusion Site Extravasation	3.2% 1/31 • Number of events 1 • up to 6 months
General disorders Injection Site Reaction	3.2% 1/31 • Number of events 1 • up to 6 months
General disorders Localized Edema	6.5% 2/31 • Number of events 2 • up to 6 months
General disorders Non-Cardiac Chest Pain	6.5% 2/31 • Number of events 2 • up to 6 months
General disorders General disorders and administration site conditions - Other, specify	3.2% 1/31 • Number of events 1 • up to 6 months
Gastrointestinal disorders Abdominal distension	3.2% 1/31 • Number of events 1 • up to 6 months
Gastrointestinal disorders Abdominal Pain	6.5% 2/31 • Number of events 2 • up to 6 months
Gastrointestinal disorders Constipation	38.7% 12/31 • Number of events 17 • up to 6 months
Gastrointestinal disorders Diarrhea	64.5% 20/31 • Number of events 41 • up to 6 months
Gastrointestinal disorders Dry Mouth	3.2% 1/31 • Number of events 1 • up to 6 months
Gastrointestinal disorders Flatulence	6.5% 2/31 • Number of events 2 • up to 6 months
Gastrointestinal disorders Hemorrhoids	3.2% 1/31 • Number of events 1 • up to 6 months
Gastrointestinal disorders Mucositis Oral	3.2% 1/31 • Number of events 3 • up to 6 months
Gastrointestinal disorders Nausea	61.3% 19/31 • Number of events 34 • up to 6 months
Gastrointestinal disorders Stomach Pain	3.2% 1/31 • Number of events 1 • up to 6 months
Gastrointestinal disorders Vomiting	29.0% 9/31 • Number of events 19 • up to 6 months
Gastrointestinal disorders Gastrointestinal disorders other, specify	3.2% 1/31 • Number of events 1 • up to 6 months
Infections and infestations Bronchial Infection	3.2% 1/31 • Number of events 1 • up to 6 months
Infections and infestations Conjunctivitis	3.2% 1/31 • Number of events 1 • up to 6 months
Infections and infestations Lip Infection	3.2% 1/31 • Number of events 1 • up to 6 months
Infections and infestations Rash Pustular	3.2% 1/31 • Number of events 1 • up to 6 months
Infections and infestations Rhinitis Infective	6.5% 2/31 • Number of events 2 • up to 6 months
Infections and infestations Urinary Tract Infection	6.5% 2/31 • Number of events 2 • up to 6 months
Infections and infestations Upper Respiratory Infection	9.7% 3/31 • Number of events 3 • up to 6 months
Infections and infestations Infections and infestations - Other, specify	6.5% 2/31 • Number of events 2 • up to 6 months
Injury, poisoning and procedural complications Fall	9.7% 3/31 • Number of events 3 • up to 6 months
Investigations Alanine aminotransferase increased	6.5% 2/31 • Number of events 2 • up to 6 months
Investigations Alkaline phosphatase increased	6.5% 2/31 • Number of events 2 • up to 6 months
Investigations Aspartate aminotransferase increased	9.7% 3/31 • Number of events 3 • up to 6 months
Investigations Blood bilirubin increased	3.2% 1/31 • Number of events 1 • up to 6 months
Investigations Cardiac troponin T increased	3.2% 1/31 • Number of events 1 • up to 6 months
Investigations Creatinine increased	9.7% 3/31 • Number of events 5 • up to 6 months
Investigations Neutrophil count decreased	64.5% 20/31 • Number of events 38 • up to 6 months
Investigations Platelet count decreased	22.6% 7/31 • Number of events 12 • up to 6 months
Investigations Weight Loss	9.7% 3/31 • Number of events 3 • up to 6 months
Investigations White blood cell decreased	38.7% 12/31 • Number of events 23 • up to 6 months
Investigations Investigations - Other,specify	3.2% 1/31 • Number of events 1 • up to 6 months
Metabolism and nutrition disorders Anorexia	45.2% 14/31 • Number of events 14 • up to 6 months
Metabolism and nutrition disorders Dehydration	6.5% 2/31 • Number of events 2 • up to 6 months
Metabolism and nutrition disorders Hypercalcemia	6.5% 2/31 • Number of events 2 • up to 6 months
Metabolism and nutrition disorders Hyperglycemia	25.8% 8/31 • Number of events 13 • up to 6 months
Metabolism and nutrition disorders Hyperkalemia	3.2% 1/31 • Number of events 1 • up to 6 months
Metabolism and nutrition disorders Hypoalbuminemia	35.5% 11/31 • Number of events 12 • up to 6 months
Metabolism and nutrition disorders Hypocalcemia	3.2% 1/31 • Number of events 1 • up to 6 months
Metabolism and nutrition disorders Hypokalemia	9.7% 3/31 • Number of events 4 • up to 6 months
Metabolism and nutrition disorders Hypomagnesemia	6.5% 2/31 • Number of events 2 • up to 6 months
Metabolism and nutrition disorders Hyponatremia	22.6% 7/31 • Number of events 7 • up to 6 months
Metabolism and nutrition disorders Hypophosphatemia	3.2% 1/31 • Number of events 1 • up to 6 months
Musculoskeletal and connective tissue disorders Back Pain	19.4% 6/31 • Number of events 11 • up to 6 months
Musculoskeletal and connective tissue disorders Bone Pain	12.9% 4/31 • Number of events 4 • up to 6 months
Musculoskeletal and connective tissue disorders Chest Wall Pain	3.2% 1/31 • Number of events 1 • up to 6 months
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	16.1% 5/31 • Number of events 5 • up to 6 months
Musculoskeletal and connective tissue disorders Myalgia	6.5% 2/31 • Number of events 2 • up to 6 months
Musculoskeletal and connective tissue disorders Pain in Extremity	9.7% 3/31 • Number of events 4 • up to 6 months
Musculoskeletal and connective tissue disorders Weakness in Extremity	3.2% 1/31 • Number of events 1 • up to 6 months
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders -Other, specify	3.2% 1/31 • Number of events 1 • up to 6 months
Nervous system disorders Dizziness	16.1% 5/31 • Number of events 5 • up to 6 months
Nervous system disorders Dysgeusia	9.7% 3/31 • Number of events 3 • up to 6 months
Nervous system disorders Headache	9.7% 3/31 • Number of events 3 • up to 6 months
Nervous system disorders Peripheral sensory neuropathy	6.5% 2/31 • Number of events 2 • up to 6 months
Nervous system disorders Presyncope	3.2% 1/31 • Number of events 1 • up to 6 months
Nervous system disorders Spinal Cord Compression	3.2% 1/31 • Number of events 1 • up to 6 months
Nervous system disorders Vasovagal Reaction	3.2% 1/31 • Number of events 1 • up to 6 months
Nervous system disorders Memory Impairment	3.2% 1/31 • Number of events 1 • up to 6 months
Psychiatric disorders Confusion	3.2% 1/31 • Number of events 1 • up to 6 months
Psychiatric disorders Depression	3.2% 1/31 • Number of events 2 • up to 6 months
Respiratory, thoracic and mediastinal disorders Cough	9.7% 3/31 • Number of events 4 • up to 6 months
Respiratory, thoracic and mediastinal disorders Dyspnea	6.5% 2/31 • Number of events 2 • up to 6 months
Respiratory, thoracic and mediastinal disorders Epitaxis	6.5% 2/31 • Number of events 5 • up to 6 months
Respiratory, thoracic and mediastinal disorders Hoarseness	3.2% 1/31 • Number of events 1 • up to 6 months
Respiratory, thoracic and mediastinal disorders Nasal Congestion	9.7% 3/31 • Number of events 3 • up to 6 months
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.2% 1/31 • Number of events 1 • up to 6 months
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	3.2% 1/31 • Number of events 1 • up to 6 months
Respiratory, thoracic and mediastinal disorders Shortness of Breath	3.2% 1/31 • Number of events 1 • up to 6 months
Respiratory, thoracic and mediastinal disorders Sore Throat	6.5% 2/31 • Number of events 2 • up to 6 months
Respiratory, thoracic and mediastinal disorders Wheezing	3.2% 1/31 • Number of events 2 • up to 6 months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	3.2% 1/31 • Number of events 1 • up to 6 months
Reproductive system and breast disorders Genital Edema	3.2% 1/31 • Number of events 1 • up to 6 months
Renal and urinary disorders Dysuria	3.2% 1/31 • Number of events 3 • up to 6 months
Renal and urinary disorders Hematuria	9.7% 3/31 • Number of events 3 • up to 6 months
Renal and urinary disorders Incomplete continence	3.2% 1/31 • Number of events 1 • up to 6 months
Renal and urinary disorders Proteinuria	3.2% 1/31 • Number of events 1 • up to 6 months
Renal and urinary disorders Urinary Frequency	3.2% 1/31 • Number of events 1 • up to 6 months
Renal and urinary disorders Urinary Incontinence	6.5% 2/31 • Number of events 2 • up to 6 months
Renal and urinary disorders Urinary Tract Pain	3.2% 1/31 • Number of events 1 • up to 6 months
Skin and subcutaneous tissue disorders Alopecia	58.1% 18/31 • Number of events 22 • up to 6 months
Skin and subcutaneous tissue disorders Dry Skin	9.7% 3/31 • Number of events 3 • up to 6 months
Skin and subcutaneous tissue disorders Pruritis	9.7% 3/31 • Number of events 3 • up to 6 months
Skin and subcutaneous tissue disorders Rash - Delayed Hypersensitivity Reaction (rash on neck, flank, leg)	3.2% 1/31 • Number of events 1 • up to 6 months
Skin and subcutaneous tissue disorders Rash Maculo-papular	19.4% 6/31 • Number of events 10 • up to 6 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	3.2% 1/31 • Number of events 1 • up to 6 months
Surgical and medical procedures Surgical and medical procedures - Other, specify	3.2% 1/31 • Number of events 1 • up to 6 months
Vascular disorders Hot Flashes	3.2% 1/31 • Number of events 1 • up to 6 months
Vascular disorders Hypertension	9.7% 3/31 • Number of events 4 • up to 6 months
Vascular disorders Hypotension	9.7% 3/31 • Number of events 3 • up to 6 months
Vascular disorders Thromborembolic event	3.2% 1/31 • Number of events 1 • up to 6 months
Vascular disorders Peripheral Ishcemia	3.2% 1/31 • Number of events 1 • up to 6 months
Eye disorders Eye disorders - Other, specify	3.2% 1/31 • Number of events 1 • up to 6 months

Additional Information

Joshua M Lang, MD, MS

Wisconsin Institutes for Medical Research

Phone: (608) 265-8131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place