Trial Outcomes & Findings for Enzalutamide With or Without Vaccine Therapy for Advanced Prostate Cancer (NCT NCT01867333)

NCT ID: NCT01867333

Last Updated: 2023-09-26

Results Overview

Time to progression is defined as the duration of time from start of treatment to time of disease progression. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions can also be considered progression if they meet the size criteria for target lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 57 participants
• Primary outcome timeframe: Median follow-up of 55.4 months
• Results posted on: 2023-09-26

Participant Flow

Participant milestones

Measure	Arm 1 - Enzalutamide Alone Enzalutamide alone Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily.	Arm 2 - Enzalutamide With Prostate-Specific Antigen (PSA)-TRICOM Enzalutamide with PSA-TRICOM PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily with vaccine given week 1 (vaccinia-PSA-TRICOM, 2x10(8) infectious units subcutaneously) and then week 3, 5 and then monthly fowlpox-vaccine (1x10(9) infectious units subcutaneously).
Overall Study STARTED	29	28
Overall Study COMPLETED	21	23
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Measure	Arm 1 - Enzalutamide Alone Enzalutamide alone Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily.	Arm 2 - Enzalutamide With Prostate-Specific Antigen (PSA)-TRICOM Enzalutamide with PSA-TRICOM PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily with vaccine given week 1 (vaccinia-PSA-TRICOM, 2x10(8) infectious units subcutaneously) and then week 3, 5 and then monthly fowlpox-vaccine (1x10(9) infectious units subcutaneously).
Overall Study Withdrawal by Subject	1	0
Overall Study Adverse Event	1	0
Overall Study Participant choice	1	2
Overall Study Complicating disease/intercurrent illness	1	0
Overall Study Death	0	1
Overall Study Physician Decision	3	2
Overall Study Switched to alternative treatment	1	0

Baseline Characteristics

Enzalutamide With or Without Vaccine Therapy for Advanced Prostate Cancer

Baseline characteristics by cohort

Measure	Arm 1 - Enzalutamide Alone n=29 Participants Enzalutamide alone Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily.	Arm 2 - Enzalutamide With Prostate-Specific Antigen (PSA)-TRICOM n=28 Participants Enzalutamide with PSA-TRICOM PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily with vaccine given week 1 (vaccinia-PSA-TRICOM, 2x10(8) infectious units subcutaneously) and then week 3, 5 and then monthly fowlpox-vaccine (1x10(9) infectious units subcutaneously).	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Age, Continuous	67.78 years STANDARD_DEVIATION 10.72 • n=5 Participants	67.12 years STANDARD_DEVIATION 10.61 • n=7 Participants	67.45 years STANDARD_DEVIATION 10.58 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	28 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: Median follow-up of 55.4 months

Time to progression is defined as the duration of time from start of treatment to time of disease progression. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions can also be considered progression if they meet the size criteria for target lesions.

Outcome measures

Measure	Arm 1 - Enzalutamide Alone n=29 Participants Enzalutamide alone Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily.	Arm 2 - Enzalutamide With Prostate-Specific Antigen (PSA)-TRICOM n=28 Participants Enzalutamide with PSA-TRICOM PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily with vaccine given week 1 (vaccinia-PSA-TRICOM, 2x10(8) infectious units subcutaneously) and then week 3, 5 and then monthly fowlpox-vaccine (1x10(9) infectious units subcutaneously).
Time to Progression (TTP)	24.2 Months Interval 16.6 to 33.1	19.1 Months Interval 8.5 to 30.3

SECONDARY outcome

Timeframe: Median potential follow-up of 68.5 months

Overall survival is defined as the date of on-study to the date of death from any cause or last follow up.

Outcome measures

Measure	Arm 1 - Enzalutamide Alone n=29 Participants Enzalutamide alone Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily.	Arm 2 - Enzalutamide With Prostate-Specific Antigen (PSA)-TRICOM n=28 Participants Enzalutamide with PSA-TRICOM PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily with vaccine given week 1 (vaccinia-PSA-TRICOM, 2x10(8) infectious units subcutaneously) and then week 3, 5 and then monthly fowlpox-vaccine (1x10(9) infectious units subcutaneously).
Overall Survival	45.6 Months Interval 26.9 to 54.7	33.8 Months Interval 20.0 to 73.2

SECONDARY outcome

Timeframe: Median follow-up of 55.4 months

PSA progression is defined by a sequence of rising values separated by >1 week (2 separate increasing values over a minimum of 2ng/ml or 25% higher (Prostate Cancer Clinical Trials Working Group (PCWG2) PSA eligibility criteria).

Outcome measures

Measure	Arm 1 - Enzalutamide Alone n=29 Participants Enzalutamide alone Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily.	Arm 2 - Enzalutamide With Prostate-Specific Antigen (PSA)-TRICOM n=28 Participants Enzalutamide with PSA-TRICOM PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily with vaccine given week 1 (vaccinia-PSA-TRICOM, 2x10(8) infectious units subcutaneously) and then week 3, 5 and then monthly fowlpox-vaccine (1x10(9) infectious units subcutaneously).
Time to Prostate-specific Antigen (PSA) Progression	11 Months Interval 6.4 to 17.5	16 Months Interval 4.6 to 38.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Measure	Arm 1 - Enzalutamide Alone n=29 Participants Enzalutamide alone Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily.	Arm 2 - Enzalutamide With Prostate-Specific Antigen (PSA)-TRICOM n=28 Participants Enzalutamide with PSA-TRICOM PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily with vaccine given week 1 (vaccinia-PSA-TRICOM, 2x10(8) infectious units subcutaneously) and then week 3, 5 and then monthly fowlpox-vaccine (1x10(9) infectious units subcutaneously).
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	29 Participants	28 Participants

Adverse Events

Arm 1 - Enzalutamide Alone

Serious events: 5 serious events

Other events: 29 other events

Deaths: 9 deaths

Arm 2 - Enzalutamide With Prostate-Specific Antigen (PSA)-TRICOM

Serious events: 9 serious events

Other events: 28 other events

Deaths: 11 deaths

Serious adverse events

Measure	Arm 1 - Enzalutamide Alone n=29 participants at risk Enzalutamide alone Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily.	Arm 2 - Enzalutamide With Prostate-Specific Antigen (PSA)-TRICOM n=28 participants at risk Enzalutamide with PSA-TRICOM PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily with vaccine given week 1 (vaccinia-PSA-TRICOM, 2x10(8) infectious units subcutaneously) and then week 3, 5 and then monthly fowlpox-vaccine (1x10(9) infectious units subcutaneously).
Gastrointestinal disorders Abdominal pain	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Dehydration	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Diarrhea	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Dizziness	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Injury, poisoning and procedural complications Fall	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
General disorders Flu like symptoms	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Injury, poisoning and procedural complications Fracture	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Vascular disorders Hypotension	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Infections and infestations - Other, acute cholecystitis	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Memory impairment	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Nervous system disorders - Other, Myasthenia Gravis Crisis	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Nervous system disorders - Other, nerve impingement was seen	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
General disorders Pain	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Pneumonia	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Sepsis	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, squamous cell removal	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Surgical and medical procedures Surgical and medical procedures - Other, Fusion, Laminectomy, and Tumor Resection	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Surgical and medical procedures Surgical and medical procedures - Other, Surgical procedure, pacemaker implantation	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Surgical and medical procedures Surgical and medical procedures - Other, percutaneous drain placement	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Surgical and medical procedures Surgical and medical procedures - Other, right knee total arthroplasty	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Vascular disorders Thromboembolic event	3.4% 1/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Urinary tract infection	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Investigations White blood cell decreased	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.

Other adverse events

Measure	Arm 1 - Enzalutamide Alone n=29 participants at risk Enzalutamide alone Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily.	Arm 2 - Enzalutamide With Prostate-Specific Antigen (PSA)-TRICOM n=28 participants at risk Enzalutamide with PSA-TRICOM PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide: An androgen receptor inhibitor. Enzalutamide will be given at the standard dose of 160 mg daily with vaccine given week 1 (vaccinia-PSA-TRICOM, 2x10(8) infectious units subcutaneously) and then week 3, 5 and then monthly fowlpox-vaccine (1x10(9) infectious units subcutaneously).
Investigations Alkaline phosphatase increased	6.9% 2/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	14.3% 4/28 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Amnesia	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Blood and lymphatic system disorders Anemia	41.4% 12/29 • Number of events 17 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	25.0% 7/28 • Number of events 12 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Anorexia	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Psychiatric disorders Anxiety	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Musculoskeletal and connective tissue disorders Arthritis	6.9% 2/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Investigations Aspartate aminotransferase increased	6.9% 2/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Atelectasis	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Cardiac disorders Atrial flutter	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Cardiac disorders Atrioventricular block first degree	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Musculoskeletal and connective tissue disorders Back pain	10.3% 3/29 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	14.3% 4/28 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Bloating	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Investigations Blood bilirubin increased	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Eye disorders Blurred vision	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Reproductive system and breast disorders Breast pain	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Investigations CD4 lymphocytes decreased	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	21.4% 6/28 • Number of events 11 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Investigations CPK increased	10.3% 3/29 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	10.7% 3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Cardiac disorders Cardiac disorders - Other, AV block 1st degree	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Eye disorders Cataract	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Cardiac disorders Chest pain - cardiac	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Musculoskeletal and connective tissue disorders Chest wall pain	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
General disorders Chills	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Investigations Alanine aminotransferase increased	6.9% 2/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	17.9% 5/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Psychiatric disorders Confusion	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Constipation	6.9% 2/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	10.7% 3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Cough	6.9% 2/29 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Investigations Creatinine increased	6.9% 2/29 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Dehydration	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Psychiatric disorders Depression	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Diarrhea	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Dizziness	13.8% 4/29 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Eye disorders Dry eye	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Dysgeusia	3.4% 1/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Dyspepsia	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Dysphagia	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
General disorders Edema limbs	3.4% 1/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Reproductive system and breast disorders Erectile dysfunction	6.9% 2/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Eye disorders Eye disorders - Other, Hx Glaucoma, pre-existing	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Eye disorders Eye disorders - Other, Iritis	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Facial nerve disorder	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Injury, poisoning and procedural complications Fall	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
General disorders Fatigue	34.5% 10/29 • Number of events 11 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	28.6% 8/28 • Number of events 12 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
General disorders Fever	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	10.7% 3/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Flatulence	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
General disorders Flu like symptoms	6.9% 2/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	25.0% 7/28 • Number of events 20 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Injury, poisoning and procedural complications Fracture	6.9% 2/29 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Gastritis	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Gastrointestinal disorders - Other, Blood in stool	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Gastrointestinal disorders - Other, EGD procedure	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Reproductive system and breast disorders Gynecomastia	13.8% 4/29 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	10.7% 3/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Headache	13.8% 4/29 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	10.7% 3/28 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Hemorrhoids	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Vascular disorders Hot flashes	24.1% 7/29 • Number of events 7 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	14.3% 4/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Hypercalcemia	20.7% 6/29 • Number of events 8 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	10.7% 3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Hyperglycemia	58.6% 17/29 • Number of events 40 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	57.1% 16/28 • Number of events 36 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Hyperkalemia	17.2% 5/29 • Number of events 11 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	21.4% 6/28 • Number of events 9 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Hypernatremia	17.2% 5/29 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Vascular disorders Hypertension	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	10.7% 3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Hyperuricemia	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Hypoalbuminemia	13.8% 4/29 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	17.9% 5/28 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Hypocalcemia	6.9% 2/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Hypoglycemia	6.9% 2/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Hyponatremia	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Metabolism and nutrition disorders Hypophosphatemia	31.0% 9/29 • Number of events 13 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	14.3% 4/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Vascular disorders Hypotension	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Endocrine disorders Hypothyroidism	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Infections and infestations - Other, C. Difficile	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Infections and infestations - Other, COVID-19 infection	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Infections and infestations - Other, Pneumonia	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Infections and infestations - Other, Soft tissue infection, Cellulitis	3.4% 1/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Infections and infestations - Other, thrush Nystatin helped-ongoing	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
General disorders Injection site reaction	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	85.7% 24/28 • Number of events 124 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, Fall	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, Pain -injury fall	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Psychiatric disorders Insomnia	6.9% 2/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
General disorders Localized edema	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Investigations Lymphocyte count decreased	41.4% 12/29 • Number of events 23 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	53.6% 15/28 • Number of events 32 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Memory impairment	3.4% 1/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, R. ankle sprain	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, closed hip (left) reduction	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	10.7% 3/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Nail infection	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Nasal congestion	13.8% 4/29 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	10.7% 3/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Nausea	13.8% 4/29 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	25.0% 7/28 • Number of events 10 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Bladder Dysplasia	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, MOHs procedure	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Nervous system disorders - Other, Myasthenia Gravis	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Nervous system disorders - Other, Spinal cord compression T-6	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Neuralgia	3.4% 1/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Investigations Neutrophil count decreased	17.2% 5/29 • Number of events 13 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	35.7% 10/28 • Number of events 24 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Oral pain	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Musculoskeletal and connective tissue disorders Osteoporosis	10.3% 3/29 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
General disorders Pain	31.0% 9/29 • Number of events 16 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	35.7% 10/28 • Number of events 16 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Musculoskeletal and connective tissue disorders Pain in extremity	13.8% 4/29 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	14.3% 4/28 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Paresthesia	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Reproductive system and breast disorders Pelvic pain	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Peripheral motor neuropathy	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Investigations Platelet count decreased	10.3% 3/29 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	14.3% 4/28 • Number of events 8 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.3% 3/29 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Nervous system disorders Presyncope	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Proctitis	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Renal and urinary disorders Proteinuria	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Skin and subcutaneous tissue disorders Pruritus	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.3% 3/29 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, RUL infiltrates	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, RLL infiltrates. As noted on CT scan	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, URI	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Rhinitis infective	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Salivary gland infection	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Cardiac disorders Sinus bradycardia	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Sinusitis	24.1% 7/29 • Number of events 9 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Fibroma	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Fungal infection	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, abrasion	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, papule	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Skin infection	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Surgical and medical procedures Surgical and medical procedures - Other, Arthroscopic	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Surgical and medical procedures Surgical and medical procedures - Other, Choleycystectomy	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Surgical and medical procedures Surgical and medical procedures - Other, Cystoscopy	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Surgical and medical procedures Surgical and medical procedures - Other, Cytoscopy	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Surgical and medical procedures Surgical and medical procedures - Other, I & D of right hand abscess	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Surgical and medical procedures Surgical and medical procedures - Other, MOHs - left ear	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Surgical and medical procedures Surgical and medical procedures - Other, Septoplasty	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Surgical and medical procedures Surgical and medical procedures - Other, TURBT	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Tooth infection	6.9% 2/29 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Toothache	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Upper respiratory infection	10.3% 3/29 • Number of events 9 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	10.7% 3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Renal and urinary disorders Urinary incontinence	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Renal and urinary disorders Urinary retention	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Infections and infestations Urinary tract infection	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Renal and urinary disorders Urinary tract obstruction	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Gastrointestinal disorders Vomiting	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	14.3% 4/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Eye disorders Watering eyes	0.00% 0/29 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Investigations Weight loss	3.4% 1/29 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	0.00% 0/28 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.
Investigations White blood cell decreased	31.0% 9/29 • Number of events 13 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.	46.4% 13/28 • Number of events 30 • Date treatment consent signed to date off study, approximately 109 months and 15 days and 110 months and 13 days for Arm 1 and Arm 2 respectively.

Additional Information

Ravi A. Madan

National Cancer Institute

Phone: 301-480-7168

Email: rm480i@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place