Trial Outcomes & Findings for Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer (NCT NCT02012296)

NCT ID: NCT02012296

Last Updated: 2022-07-13

Results Overview

PSA progression was defined as a PSA that is ≥1.25 times (25% increase) the PSA at randomization (week 12) and an absolute 5 ng/ml increase. PSA progression-free survival is PSA progression or death from any cause.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

88 participants

Primary outcome timeframe

Up to 3 years, measured from randomization

Results posted on

2022-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Enzalutamide) Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 160 mg daily per standard of care. enzalutamide: Given PO laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	Treatment (Enzalutamide, Mifepristone) Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 120 mg daily plus mifepristone 300 mg daily. enzalutamide: Given PO mifepristone: Given PO laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	Not Randomized Patients received Enzalutamide 160 mg daily during a 12-week lead-in.
Overall Study STARTED	33	33	22
Overall Study COMPLETED	33	32	0
Overall Study NOT COMPLETED	0	1	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Enzalutamide, Mifepristone) Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 120 mg daily plus mifepristone 300 mg daily. enzalutamide: Given PO mifepristone: Given PO laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	Not Randomized Patients received Enzalutamide 160 mg daily during a 12-week lead-in.
Overall Study Lack of Efficacy	0	15
Overall Study Adverse Event	0	2
Overall Study Early study closure	0	5
Overall Study Protocol Violation	1	0

Baseline Characteristics

Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Enzalutamide) n=33 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 160 mg daily per standard of care. enzalutamide: Given PO	Treatment (Enzalutamide, Mifepristone) n=33 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 120 mg daily plus mifepristone 300 mg daily. enzalutamide: Given PO mifepristone: Given PO	Not Randomized n=22 Participants Patients received enzalutamide 160 mg daily during a 12-week lead-in.	Total n=88 Participants Total of all reporting groups
Age, Continuous	71 years n=93 Participants	71 years n=4 Participants	68 years n=27 Participants	70 years n=483 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Sex: Female, Male Male	33 Participants n=93 Participants	33 Participants n=4 Participants	22 Participants n=27 Participants	88 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	9 Participants n=93 Participants	7 Participants n=4 Participants	3 Participants n=27 Participants	19 Participants n=483 Participants
Race (NIH/OMB) White	20 Participants n=93 Participants	26 Participants n=4 Participants	16 Participants n=27 Participants	62 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants	5 Participants n=483 Participants
Region of Enrollment United States	33 participants n=93 Participants	33 participants n=4 Participants	22 participants n=27 Participants	66 participants n=483 Participants

PRIMARY outcome

Timeframe: Up to 3 years, measured from randomization

Population: Patients not randomized were not evaluated for PSA progression-free survival.

Outcome measures

Outcome measures
Measure	Treatment (Enzalutamide) n=33 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 160 mg daily per standard of care. enzalutamide: Given PO	Treatment (Enzalutamide, Mifepristone) n=32 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 120 mg daily plus mifepristone 300 mg daily. enzalutamide: Given PO mifepristone: Given PO	Not Randomized Received enzalutamide160 mg daily during a 12-week lead-in.
PSA Progression-free Survival	20.8 Months Interval 8.3 to Upper confidence limit cannot be estimated due to insufficient number of participants with events.	16.5 Months Interval 8.4 to Upper confidence limit cannot be estimated due to insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: Up to 3 years, measured from randomization

Population: Patients not randomized were not evaluated for radiographic progression-free survival.

Radiographic progression or death from any cause.

Outcome measures

Outcome measures
Measure	Treatment (Enzalutamide) n=33 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 160 mg daily per standard of care. enzalutamide: Given PO	Treatment (Enzalutamide, Mifepristone) n=32 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 120 mg daily plus mifepristone 300 mg daily. enzalutamide: Given PO mifepristone: Given PO	Not Randomized Received enzalutamide160 mg daily during a 12-week lead-in.
Radiographic PFS	NA Months Interval 8.4 to Median and upper confidence limit cannot be estimated due to insufficient number of participants with events	16.5 Months Interval 8.3 to Upper confidence limit cannot be estimated due to insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: Week 12 (randomization)

Population: Number of patients with circulating tumor cells.

Positive/negative classification with positive defined as a cytokeratin cell for whom there was an androgen receptor \> 0

Outcome measures

Outcome measures
Measure	Treatment (Enzalutamide) n=23 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 160 mg daily per standard of care. enzalutamide: Given PO	Treatment (Enzalutamide, Mifepristone) n=13 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 120 mg daily plus mifepristone 300 mg daily. enzalutamide: Given PO mifepristone: Given PO	Not Randomized n=6 Participants Received enzalutamide160 mg daily during a 12-week lead-in.
Number of Participants With Positive AR Expression Within Circulating Tumor Cells (CTCs)	16 Participants	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 12 (randomization)

Population: Patients with circulating tumor cells (CTCs).

Positive/negative classification with positive defined as a cytokeratin cell for whom there was an glucocorticoid receptor \> 0

Outcome measures

Outcome measures
Measure	Treatment (Enzalutamide) n=23 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 160 mg daily per standard of care. enzalutamide: Given PO	Treatment (Enzalutamide, Mifepristone) n=13 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 120 mg daily plus mifepristone 300 mg daily. enzalutamide: Given PO mifepristone: Given PO	Not Randomized n=6 Participants Received enzalutamide160 mg daily during a 12-week lead-in.
Number of Participants With Positive GR Expression Within Circulating Tumor Cells (CTCs)	17 Participants	8 Participants	5 Participants

SECONDARY outcome

Timeframe: 12 to 16 weeks

Population: 6 patients in the enzalutamide arm and 7 patients in the enzalutamide plus mifepristone arm had missing data. Patients not randomized were not evaluated for changes in testosterone.

Change from week 12 to week 16

Outcome measures

Outcome measures
Measure	Treatment (Enzalutamide) n=27 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 160 mg daily per standard of care. enzalutamide: Given PO	Treatment (Enzalutamide, Mifepristone) n=25 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 120 mg daily plus mifepristone 300 mg daily. enzalutamide: Given PO mifepristone: Given PO	Not Randomized Received enzalutamide160 mg daily during a 12-week lead-in.
Testosterone	0.6 ng/dL Standard Error 1.2	21.0 ng/dL Standard Error 6.0	—

SECONDARY outcome

Timeframe: 12 to 16 weeks

Population: 13 patients in the enzalutamide arm and 2 patients in the enzalutamide plus mifepristone arm had missing data. Patients not randomized were not evaluated for changes in TSH.

Change in log(TSH) from week 12 to week 16

Outcome measures

Outcome measures
Measure	Treatment (Enzalutamide) n=20 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 160 mg daily per standard of care. enzalutamide: Given PO	Treatment (Enzalutamide, Mifepristone) n=30 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 120 mg daily plus mifepristone 300 mg daily. enzalutamide: Given PO mifepristone: Given PO	Not Randomized Received enzalutamide160 mg daily during a 12-week lead-in.
Thyroid Stimulating Hormone	-0.121 log(mcU/mL) Standard Error 0.037	0.306 log(mcU/mL) Standard Error 0.097	—

SECONDARY outcome

Timeframe: 12 to 16 weeks

Population: 12 patients in the enzalutamide arm and 1 patient in the enzalutamide plus mifepristone arm had missing data. Patients not randomized were not evaluated for changes in cortisol.

Change in log(Cortisol) from week 12 to week 16

Outcome measures

Outcome measures
Measure	Treatment (Enzalutamide) n=21 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 160 mg daily per standard of care. enzalutamide: Given PO	Treatment (Enzalutamide, Mifepristone) n=31 Participants Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 120 mg daily plus mifepristone 300 mg daily. enzalutamide: Given PO mifepristone: Given PO	Not Randomized Received enzalutamide160 mg daily during a 12-week lead-in.
Cortisol	0.072 log(ug/dL) Standard Error 0.126	0.733 log(ug/dL) Standard Error 0.102	—

Adverse Events

Treatment (Enzalutamide)

Serious events: 3 serious events

Other events: 33 other events

Deaths: 0 deaths

Treatment (Enzalutamide, Mifepristone)

Serious events: 6 serious events

Other events: 30 other events

Deaths: 1 deaths

Not Randomized

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Enzalutamide) n=33 participants at risk Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 160 mg daily per standard of care. enzalutamide: Given PO	Treatment (Enzalutamide, Mifepristone) n=33 participants at risk Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 120 mg daily plus mifepristone 300 mg daily. enzalutamide: Given PO mifepristone: Given PO	Not Randomized n=22 participants at risk Patients received enzalutamide 160 mg daily during 12-week lead-in.
Gastrointestinal disorders Abdominal pain	3.0% 1/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Infections and infestations Infections and infestations - Other	3.0% 1/33 • Up to 1 year	0.00% 0/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Gastrointestinal disorders Vomiting	3.0% 1/33 • Up to 1 year	0.00% 0/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Metabolism and nutrition disorders Anorexia	0.00% 0/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Nervous system disorders Headache	0.00% 0/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Vascular disorders Hypertension	0.00% 0/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Gastrointestinal disorders Ileus	0.00% 0/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	0.00% 0/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Investigations Neutrophil count decreased	0.00% 0/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
General disorders Non-cardiac chest pain	0.00% 0/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Renal and urinary disorders Urinary retention	0.00% 0/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Investigations White blood cell decreased	0.00% 0/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Cardiac disorders Atrial fibrillation	0.00% 0/33 • Up to 1 year	0.00% 0/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Cardiac disorders Heart failure	0.00% 0/33 • Up to 1 year	0.00% 0/33 • Up to 1 year	4.5% 1/22 • Up to 1 year

Other adverse events

Other adverse events
Measure	Treatment (Enzalutamide) n=33 participants at risk Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 160 mg daily per standard of care. enzalutamide: Given PO	Treatment (Enzalutamide, Mifepristone) n=33 participants at risk Patients receive enzalutamide 160 mg daily during a 12-week lead-in followed by enzalutamide 120 mg daily plus mifepristone 300 mg daily. enzalutamide: Given PO mifepristone: Given PO	Not Randomized n=22 participants at risk Patients received enzalutamide 160 mg daily during 12-week lead-in.
Gastrointestinal disorders Abdominal pain	12.1% 4/33 • Up to 1 year	12.1% 4/33 • Up to 1 year	9.1% 2/22 • Up to 1 year
Investigations Alkaline phosphatase increase	6.1% 2/33 • Up to 1 year	0.00% 0/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Blood and lymphatic system disorders Anemia	9.1% 3/33 • Up to 1 year	0.00% 0/33 • Up to 1 year	9.1% 2/22 • Up to 1 year
Metabolism and nutrition disorders Anorexia	15.2% 5/33 • Up to 1 year	42.4% 14/33 • Up to 1 year	22.7% 5/22 • Up to 1 year
Psychiatric disorders Anxiety	15.2% 5/33 • Up to 1 year	9.1% 3/33 • Up to 1 year	18.2% 4/22 • Up to 1 year
Musculoskeletal and connective tissue disorders Arthralgia	18.2% 6/33 • Up to 1 year	15.2% 5/33 • Up to 1 year	13.6% 3/22 • Up to 1 year
Musculoskeletal and connective tissue disorders Arthritis	12.1% 4/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Musculoskeletal and connective tissue disorders Back pain	24.2% 8/33 • Up to 1 year	21.2% 7/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Investigations Blood bilirubin increased	6.1% 2/33 • Up to 1 year	0.00% 0/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Eye disorders Blurred vision	6.1% 2/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	9.1% 2/22 • Up to 1 year
Musculoskeletal and connective tissue disorders Bone pain	12.1% 4/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	9.1% 2/22 • Up to 1 year
Psychiatric disorders Confusion	6.1% 2/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Gastrointestinal disorders Constipation	12.1% 4/33 • Up to 1 year	39.4% 13/33 • Up to 1 year	13.6% 3/22 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Cough	12.1% 4/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Psychiatric disorders Depression	15.2% 5/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Gastrointestinal disorders Diarrhea	30.3% 10/33 • Up to 1 year	18.2% 6/33 • Up to 1 year	13.6% 3/22 • Up to 1 year
Nervous system disorders Dizziness	18.2% 6/33 • Up to 1 year	18.2% 6/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Gastrointestinal disorders Dyspepsia	6.1% 2/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Dyspnea	18.2% 6/33 • Up to 1 year	9.1% 3/33 • Up to 1 year	9.1% 2/22 • Up to 1 year
General disorders Edema limbs	15.2% 5/33 • Up to 1 year	9.1% 3/33 • Up to 1 year	9.1% 2/22 • Up to 1 year
Injury, poisoning and procedural complications Fall	12.1% 4/33 • Up to 1 year	12.1% 4/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
General disorders Fatigue	75.8% 25/33 • Up to 1 year	81.8% 27/33 • Up to 1 year	63.6% 14/22 • Up to 1 year
Musculoskeletal and connective tissue disorders Flank pain	9.1% 3/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Musculoskeletal and connective tissue disorders Generalized muscle weakness	9.1% 3/33 • Up to 1 year	27.3% 9/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Reproductive system and breast disorders Genital edema	9.1% 3/33 • Up to 1 year	0.00% 0/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Nervous system disorders Headache	15.2% 5/33 • Up to 1 year	18.2% 6/33 • Up to 1 year	9.1% 2/22 • Up to 1 year
Renal and urinary disorders Hematuria	9.1% 3/33 • Up to 1 year	12.1% 4/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Vascular disorders Hot flashes	57.6% 19/33 • Up to 1 year	45.5% 15/33 • Up to 1 year	27.3% 6/22 • Up to 1 year
Metabolism and nutrition disorders Hyperglycemia	27.3% 9/33 • Up to 1 year	9.1% 3/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Vascular disorders Hypertension	15.2% 5/33 • Up to 1 year	18.2% 6/33 • Up to 1 year	9.1% 2/22 • Up to 1 year
Psychiatric disorders Insomnia	9.1% 3/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Nervous system disorders Memory impairment	9.1% 3/33 • Up to 1 year	12.1% 4/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	6.1% 2/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
General disorders Nausea	18.2% 6/33 • Up to 1 year	18.2% 6/33 • Up to 1 year	13.6% 3/22 • Up to 1 year
General disorders Pain	30.3% 10/33 • Up to 1 year	27.3% 9/33 • Up to 1 year	13.6% 3/22 • Up to 1 year
Musculoskeletal and connective tissue disorders Pain in extremity	15.2% 5/33 • Up to 1 year	12.1% 4/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Nervous system disorders Peripheral sensory neuropathy	6.1% 2/33 • Up to 1 year	12.1% 4/33 • Up to 1 year	18.2% 4/22 • Up to 1 year
Investigations Platelet count decreased	9.1% 3/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Skin and subcutaneous tissue disorders Pruritis	9.1% 3/33 • Up to 1 year	0.00% 0/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Renal and urinary disorders Renal and urinary disorders - Other	6.1% 2/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Renal and urinary disorders Renal calculi	6.1% 2/33 • Up to 1 year	0.00% 0/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Sinus disorder	6.1% 2/33 • Up to 1 year	0.00% 0/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	6.1% 2/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Renal and urinary disorders Urinary frequency	12.1% 4/33 • Up to 1 year	12.1% 4/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Renal and urinary disorders Urinary incontinence	9.1% 3/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Gastrointestinal disorders Vomiting	6.1% 2/33 • Up to 1 year	12.1% 4/33 • Up to 1 year	13.6% 3/22 • Up to 1 year
Skin and subcutaneous tissue disorders Alopecia	3.0% 1/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Reproductive system and breast disorders Breast pain	0.00% 0/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Renal and urinary disorders Cystitis noninfective	3.0% 1/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Ear and labyrinth disorders Ear pain	0.00% 0/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
General disorders Flu like symptoms	0.00% 0/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	4.5% 1/22 • Up to 1 year
Injury, poisoning and procedural complications Fracture	3.0% 1/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
General disorders General disorders and administration site conditions - Other	3.0% 1/33 • Up to 1 year	9.1% 3/33 • Up to 1 year	9.1% 2/22 • Up to 1 year
Metabolism and nutrition disorders Hypokalemia	3.0% 1/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Investigations Investigations - Other	0.00% 0/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Nervous system disorders Paresthesia	0.00% 0/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Reproductive system and breast disorders Pelvic pain	0.00% 0/33 • Up to 1 year	9.1% 3/33 • Up to 1 year	9.1% 2/22 • Up to 1 year
Infections and infestations Upper respiratory infection	3.0% 1/33 • Up to 1 year	15.2% 5/33 • Up to 1 year	18.2% 4/22 • Up to 1 year
Renal and urinary disorders Urinary retention	0.00% 0/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Eye disorders Watering eyes	0.00% 0/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Investigations Weight gain	3.0% 1/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Investigations Weight loss	0.00% 0/33 • Up to 1 year	15.2% 5/33 • Up to 1 year	9.1% 2/22 • Up to 1 year
Investigations White blood cell decreased	0.00% 0/33 • Up to 1 year	6.1% 2/33 • Up to 1 year	0.00% 0/22 • Up to 1 year
Infections and infestations Skin infection	3.0% 1/33 • Up to 1 year	3.0% 1/33 • Up to 1 year	9.1% 2/22 • Up to 1 year
General disorders Non-cardiac chest pain	0.00% 0/33 • Up to 1 year	0.00% 0/33 • Up to 1 year	9.1% 2/22 • Up to 1 year

Additional Information

Theodore Karrison

University of Chicago

Phone: 773-702-9326

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place