Trial Outcomes & Findings for Safety and Efficacy Studies of Panobinostat and Bicalutamide in Patients With Recurrent Prostate Cancer After Castration (NCT NCT00878436)
NCT ID: NCT00878436
Last Updated: 2018-02-07
Results Overview
measured by PSA and /or metastases progression criteria by body CT following RECIST criteria 1.1 and/or bones scan following the appearance of at least 2 new bone metastases and confirmation of 2 additional bone metastasis on a subsequent bone scan 6-8 weeks later and/or clinical progression. Only participants who completed two or more treatment cycles were assessed for this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
9 months
Results posted on
2018-02-07
Participant Flow
Members of the research team have attempted to contact the PI, unsuccessfully, and are unable to answer questions regarding results.
Participant milestones
| Measure |
LBH 40mg
Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
|
LBH 20mg
Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
24
|
|
Overall Study
Completed 2 Cycles
|
21
|
20
|
|
Overall Study
6 Months
|
8
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
23
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Studies of Panobinostat and Bicalutamide in Patients With Recurrent Prostate Cancer After Castration
Baseline characteristics by cohort
| Measure |
LBH 40mg
n=28 Participants
Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
|
LBH 20mg
n=24 Participants
Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
69 years
n=7 Participants
|
69 years
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
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 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
|
0 Participants
n=5 Participants
|
1 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsmeasured by PSA and /or metastases progression criteria by body CT following RECIST criteria 1.1 and/or bones scan following the appearance of at least 2 new bone metastases and confirmation of 2 additional bone metastasis on a subsequent bone scan 6-8 weeks later and/or clinical progression. Only participants who completed two or more treatment cycles were assessed for this outcome measure.
Outcome measures
| Measure |
LBH 40mg
n=21 Participants
Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
|
LBH 20mg
n=20 Participants
Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
|
|---|---|---|
|
Percentage of Patients Free of Progression and Without Symptomatic Deterioration
|
24 percentage of Participants
|
9 percentage of Participants
|
PRIMARY outcome
Timeframe: 6 monthsmeasured by PSA and /or metastases progression criteria by body CT following RECIST criteria 1.1 and/or bones scan following the appearance of at least 2 new bone metastases and confirmation of 2 additional bone metastasis on a subsequent bone scan 6-8 weeks later and/or clinical progression. Only participants who completed two or more treatment cycles were assessed for this outcome measure.
Outcome measures
| Measure |
LBH 40mg
n=21 Participants
Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
|
LBH 20mg
n=20 Participants
Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
|
|---|---|---|
|
Percentage of Patients Free of Progression and Without Symptomatic Deterioration
|
42 percentage of participants
|
19 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Unable to locate PI for secondary outcome measure results. Data is not available.
PSA progression is defined as a 25% or greater increase in PSA and an absolute increase value of 2 ng/ml or more over a nadir or baseline documented and confirmed by a second value three weeks later
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 monthsPopulation: Unable to locate PI for secondary outcome measure results. Data is not available.
Unable to locate PI for secondary outcome measure results. Data is not available.
Outcome measures
Outcome data not reported
Adverse Events
LBH 40mg
Serious events: 11 serious events
Other events: 26 other events
Deaths: 0 deaths
LBH 20mg
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LBH 40mg
n=28 participants at risk
Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
|
LBH 20mg
n=24 participants at risk
Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
|
|---|---|---|
|
Renal and urinary disorders
Acute Renal Failure
|
3.6%
1/28
|
0.00%
0/24
|
|
Cardiac disorders
Cardiac Asystole
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Chest Pain
|
3.6%
1/28
|
0.00%
0/24
|
|
Surgical and medical procedures
Cord Compression
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Dehydration
|
3.6%
1/28
|
8.3%
2/24
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28
|
0.00%
0/24
|
|
Nervous system disorders
Dizziness
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Fatigue
|
3.6%
1/28
|
0.00%
0/24
|
|
General disorders
Fever
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Karposi Sarcoma
|
0.00%
0/28
|
4.2%
1/24
|
|
Blood and lymphatic system disorders
Myelodysplasia
|
0.00%
0/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/28
|
4.2%
1/24
|
|
Surgical and medical procedures
Pleural Effusion
|
0.00%
0/28
|
4.2%
1/24
|
|
Cardiac disorders
Qtc Prolonged
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Stomach Pain
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Subarachoid Hemorrhage
|
0.00%
0/28
|
4.2%
1/24
|
|
Blood and lymphatic system disorders
Subdural Hematoma
|
0.00%
0/28
|
4.2%
1/24
|
|
Nervous system disorders
Syncope
|
10.7%
3/28
|
4.2%
1/24
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.9%
5/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Ulcers
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
2/28
|
0.00%
0/24
|
Other adverse events
| Measure |
LBH 40mg
n=28 participants at risk
Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
|
LBH 20mg
n=24 participants at risk
Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
|
|---|---|---|
|
Metabolism and nutrition disorders
Albumin
|
3.6%
1/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Altered Taste
|
7.1%
2/28
|
4.2%
1/24
|
|
Blood and lymphatic system disorders
Anc
|
0.00%
0/28
|
4.2%
1/24
|
|
Blood and lymphatic system disorders
Anemia
|
10.7%
3/28
|
12.5%
3/24
|
|
Gastrointestinal disorders
Anorexia
|
25.0%
7/28
|
8.3%
2/24
|
|
Psychiatric disorders
Anxiety
|
10.7%
3/28
|
4.2%
1/24
|
|
General disorders
Back Pain
|
7.1%
2/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Bilateral Lower Extremity Edema
|
3.6%
1/28
|
0.00%
0/24
|
|
Renal and urinary disorders
Bladder Outlet Obstruction
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Bloating / Distention
|
3.6%
1/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Blotches
|
0.00%
0/28
|
4.2%
1/24
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/28
|
4.2%
1/24
|
|
Reproductive system and breast disorders
Breast Enlargement
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Breast Pain
|
3.6%
1/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Bruising
|
3.6%
1/28
|
0.00%
0/24
|
|
Infections and infestations
Burning, Foul Smelling Urination
|
0.00%
0/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Change In Taste
|
7.1%
2/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pressure
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Chills
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Ck Elevated
|
0.00%
0/28
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Cold Sore
|
0.00%
0/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Constipation
|
21.4%
6/28
|
25.0%
6/24
|
|
Metabolism and nutrition disorders
Cpk
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Creatinine
|
3.6%
1/28
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Creatinine Increased
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Decreased Albumin
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Decreased Appetite
|
14.3%
4/28
|
16.7%
4/24
|
|
Metabolism and nutrition disorders
Decreased Bicarbonates
|
3.6%
1/28
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Decreased Cpk
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Decreased Creatinine
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Decreased Platelets
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Decreased Sodium
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Dehydration
|
3.6%
1/28
|
4.2%
1/24
|
|
Infections and infestations
Dental Abscess
|
3.6%
1/28
|
4.2%
1/24
|
|
Psychiatric disorders
Depression
|
7.1%
2/28
|
8.3%
2/24
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
14/28
|
25.0%
6/24
|
|
Psychiatric disorders
Distracted/Concentration Impairment
|
3.6%
1/28
|
0.00%
0/24
|
|
Nervous system disorders
Dizziness
|
21.4%
6/28
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Dry Cough
|
0.00%
0/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Dry Mouth
|
3.6%
1/28
|
8.3%
2/24
|
|
Gastrointestinal disorders
Dyspepsia
|
10.7%
3/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.6%
1/28
|
0.00%
0/24
|
|
General disorders
Early Satiety
|
0.00%
0/28
|
4.2%
1/24
|
|
Blood and lymphatic system disorders
Edema- Leg
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Edema- Pedal
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Elevated Alkaline Phosphatase
|
0.00%
0/28
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Elevated Bun
|
0.00%
0/28
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Elevated Creatinine
|
3.6%
1/28
|
8.3%
2/24
|
|
Cardiac disorders
Elevated Qtc
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Enlarged L Neck Node (Bl)
|
3.6%
1/28
|
0.00%
0/24
|
|
General disorders
Epigastric Pain
|
3.6%
1/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Facial Erythematous
|
3.6%
1/28
|
0.00%
0/24
|
|
General disorders
Fatigue
|
50.0%
14/28
|
66.7%
16/24
|
|
Gastrointestinal disorders
Flatulence
|
3.6%
1/28
|
4.2%
1/24
|
|
General disorders
Flu Like Symptoms
|
0.00%
0/28
|
4.2%
1/24
|
|
Injury, poisoning and procedural complications
Fracture Right Heel
|
3.6%
1/28
|
0.00%
0/24
|
|
General disorders
Generalized Aches
|
0.00%
0/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Gerd
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Gfr
|
3.6%
1/28
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Hair Loss
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Headache
|
10.7%
3/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Heartburn
|
3.6%
1/28
|
8.3%
2/24
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
0.00%
0/28
|
4.2%
1/24
|
|
Renal and urinary disorders
Hematuria
|
10.7%
3/28
|
4.2%
1/24
|
|
Endocrine disorders
Hot Flashes
|
0.00%
0/28
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/28
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.6%
1/28
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Hypermagnesmia
|
3.6%
1/28
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Hypertryglyceridemia
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hypomagnesia
|
0.00%
0/28
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.6%
1/28
|
0.00%
0/24
|
|
Ear and labyrinth disorders
Imbalance
|
3.6%
1/28
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Increased Creatinine
|
10.7%
3/28
|
8.3%
2/24
|
|
Gastrointestinal disorders
Increased Dyspepsia
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Increased Fatigue
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Increased Ldh
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Increased Nausea
|
3.6%
1/28
|
0.00%
0/24
|
|
Endocrine disorders
Increased Tsh
|
0.00%
0/28
|
4.2%
1/24
|
|
Infections and infestations
Infection- It. Pylori
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
L Eye Conjunctival Hemorrhage
|
3.6%
1/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
L Hip Pain From Fall
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Left Jaw Pain
|
3.6%
1/28
|
0.00%
0/24
|
|
General disorders
Left Sciatic Pain
|
0.00%
0/28
|
4.2%
1/24
|
|
Blood and lymphatic system disorders
Left Scleral Hemorrhage
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Leg Edema
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.6%
1/28
|
0.00%
0/24
|
|
Nervous system disorders
Light Headed
|
0.00%
0/28
|
8.3%
2/24
|
|
Musculoskeletal and connective tissue disorders
Little Shakey
|
0.00%
0/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Loose Stools
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Loss Of Appetite
|
3.6%
1/28
|
0.00%
0/24
|
|
General disorders
Low Back Pain
|
0.00%
0/28
|
4.2%
1/24
|
|
Cardiac disorders
Low Blood Pressure
|
3.6%
1/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Low Phosphorus
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Low Platelets
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Lower Extremity Edema
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Metallic Taste
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Mild Nausea
|
0.00%
0/28
|
4.2%
1/24
|
|
Psychiatric disorders
Mood Changes
|
0.00%
0/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Mucositis- Oral Cavity
|
3.6%
1/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
3.6%
1/28
|
4.2%
1/24
|
|
General disorders
Nasal Stuffiness
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
46.4%
13/28
|
37.5%
9/24
|
|
Gastrointestinal disorders
Neck Pain
|
0.00%
0/28
|
4.2%
1/24
|
|
Nervous system disorders
Neuropathy (Bl)
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.9%
5/28
|
0.00%
0/24
|
|
General disorders
Night Sweats
|
0.00%
0/28
|
4.2%
1/24
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/28
|
4.2%
1/24
|
|
Blood and lymphatic system disorders
Nose Bleeds
|
3.6%
1/28
|
0.00%
0/24
|
|
Eye disorders
Occipital Pain
|
3.6%
1/28
|
0.00%
0/24
|
|
General disorders
Pain
|
3.6%
1/28
|
4.2%
1/24
|
|
General disorders
Pain, Intermittent
|
0.00%
0/28
|
4.2%
1/24
|
|
Blood and lymphatic system disorders
Petechial Rash (Arms & Legs)
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Platelets
|
3.6%
1/28
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Platelets Decreased
|
3.6%
1/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
R Upper Chest Anular Erythema
|
3.6%
1/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Rear Pelvic Left Hip Pain
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Rib Pain
|
0.00%
0/28
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Right Flank Bruise
|
3.6%
1/28
|
0.00%
0/24
|
|
General disorders
Sacral Pain, Intermittent
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Severe Fatigue
|
0.00%
0/28
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Shoulder Pain
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Sinus Congestion
|
3.6%
1/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Skin Dermatitis
|
3.6%
1/28
|
0.00%
0/24
|
|
Infections and infestations
Skin Infection
|
0.00%
0/28
|
4.2%
1/24
|
|
Infections and infestations
Skin Infection Llq
|
0.00%
0/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Stomach Cramp
|
7.1%
2/28
|
0.00%
0/24
|
|
General disorders
Sweating
|
3.6%
1/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Swelling Leg
|
0.00%
0/28
|
4.2%
1/24
|
|
Nervous system disorders
Syncope
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Taste Changes
|
10.7%
3/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Tenesmus
|
0.00%
0/28
|
4.2%
1/24
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
39.3%
11/28
|
37.5%
9/24
|
|
Ear and labyrinth disorders
Tinniyus
|
3.6%
1/28
|
0.00%
0/24
|
|
Infections and infestations
Tooth Infection
|
3.6%
1/28
|
0.00%
0/24
|
|
Nervous system disorders
Tremor
|
0.00%
0/28
|
4.2%
1/24
|
|
Infections and infestations
Upper Respiratory Infection
|
10.7%
3/28
|
4.2%
1/24
|
|
Renal and urinary disorders
Urinary Frequency
|
3.6%
1/28
|
8.3%
2/24
|
|
Renal and urinary disorders
Urinary Incontinence (Bl)
|
3.6%
1/28
|
0.00%
0/24
|
|
Renal and urinary disorders
Urinary Retention
|
3.6%
1/28
|
0.00%
0/24
|
|
Infections and infestations
Urinary Tract Infection
|
3.6%
1/28
|
4.2%
1/24
|
|
Cardiac disorders
Vasovagal Syncope
|
3.6%
1/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Ventral Hernia
|
0.00%
0/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
4/28
|
8.3%
2/24
|
|
Gastrointestinal disorders
Vomiting (1 Episode)
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Vomitting, Occasion
|
3.6%
1/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Weak Finger Nails
|
0.00%
0/28
|
4.2%
1/24
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
3.6%
1/28
|
0.00%
0/24
|
|
General disorders
Weight Loss
|
17.9%
5/28
|
8.3%
2/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place