Trial Outcomes & Findings for Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer (NCT NCT00170157)
NCT ID: NCT00170157
Last Updated: 2017-05-15
Results Overview
PSA progression is defined as a rise in PSA to \>4.0 ng/mL demonstrated twice in measurements taken two weeks apart.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
18 months from the start of AA therapy
Results posted on
2017-05-15
Participant Flow
112 participants were recruited between June 2004 and June 2009 at Mayo Clinic.
All participants were initially randomized to either arm.
Participant milestones
| Measure |
Androgen Ablative (AA) Therapy + MDX-010
3 months of concurrent androgen ablative (AA) therapy + MDX-010
Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.
MDX-010 is received as an infusion at a dose of 3.0 mg/kg on day 7.
|
Androgen Ablative (AA) Then AA Therapy + MDX-010
3 months of initial AA therapy alone
Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.
|
|---|---|---|
|
Treatment Period 1 Initial Randomization
STARTED
|
54
|
58
|
|
Treatment Period 1 Initial Randomization
COMPLETED
|
54
|
58
|
|
Treatment Period 1 Initial Randomization
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 14 Days
STARTED
|
0
|
58
|
|
Washout Period of 14 Days
COMPLETED
|
0
|
41
|
|
Washout Period of 14 Days
NOT COMPLETED
|
0
|
17
|
|
Treatment Period 2 Crossover
STARTED
|
0
|
41
|
|
Treatment Period 2 Crossover
COMPLETED
|
0
|
41
|
|
Treatment Period 2 Crossover
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=112 Participants
All participants initially randomized.
|
|---|---|
|
Age, Customized
<= 39
|
0 participants
n=5 Participants
|
|
Age, Customized
40-49
|
5 participants
n=5 Participants
|
|
Age, Customized
50-59
|
29 participants
n=5 Participants
|
|
Age, Customized
60-69
|
48 participants
n=5 Participants
|
|
Age, Customized
>= 70
|
30 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 months from the start of AA therapyPSA progression is defined as a rise in PSA to \>4.0 ng/mL demonstrated twice in measurements taken two weeks apart.
Outcome measures
| Measure |
Entire Study Population
n=112 Participants
All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone) initially randomized (i.e., before cross-over) were grouped together for this outcome.
.
|
Androgen Ablative (AA) Then AA Therapy + MDX-010
3 months of initial AA therapy alone
Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily
|
|---|---|---|
|
Number of Participants Progression-free at 18 Months
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 105 participants had follow-up PSA information; those without a follow-up PSA were excluded from this analysis.
Percent of participants who had undetectable PSA at 3 months on the initially assigned treatment arm (prior to crossing over).
Outcome measures
| Measure |
Entire Study Population
n=53 Participants
All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone) initially randomized (i.e., before cross-over) were grouped together for this outcome.
.
|
Androgen Ablative (AA) Then AA Therapy + MDX-010
n=52 Participants
3 months of initial AA therapy alone
Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily
|
|---|---|---|
|
Percent of Participants With Undetectable Prostate-specific Antigen (PSA) Response
|
55 percentage of participants
|
39 percentage of participants
|
Adverse Events
Entire Study Population
Serious events: 10 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entire Study Population
n=110 participants at risk
All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone the AA Therapy + MDX-010) were grouped together for this outcome.
|
|---|---|
|
Cardiac disorders
Ischemia/Infarction
|
1.8%
2/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Eye disorders
Vision-Blurred
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Gastrointestinal disorders
Diarrhea-No Colostom
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Gastrointestinal disorders
Pain-Abdominal
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Hepatobiliary disorders
Hepatic
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Immune system disorders
Hypersensitivity
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Alkaline phosphatase
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Amylase
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Creatinine
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Lipase increased
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.8%
2/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Vascular disorders
Hypertension
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Vascular disorders
Thrombosis
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
Other adverse events
| Measure |
Entire Study Population
n=110 participants at risk
All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone the AA Therapy + MDX-010) were grouped together for this outcome.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
19.1%
21/110 • Number of events 34
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.91%
1/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Cardiac disorders
Cardiovascular
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Endocrine disorders
Endocrine
|
3.6%
4/110 • Number of events 5
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Eye disorders
Vision
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Eye disorders
Vision-Blurred
|
21.8%
24/110 • Number of events 44
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Gastrointestinal disorders
Colitis
|
1.8%
2/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
1.8%
2/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Gastrointestinal disorders
Diarrhea-No Colostom
|
7.3%
8/110 • Number of events 8
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.4%
7/110 • Number of events 7
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Gastrointestinal disorders
Pain-Abdominal
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
General disorders
Constitutional Symptoms
|
4.5%
5/110 • Number of events 5
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
General disorders
Edema: Limb
|
2.7%
3/110 • Number of events 4
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
General disorders
Facial pain
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
General disorders
Fatigue
|
71.8%
79/110 • Number of events 160
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
General disorders
Pain-Chest
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
General disorders
Rigors
|
1.8%
2/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Hepatobiliary disorders
Hepatic
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Immune system disorders
Hypersensitivity
|
2.7%
3/110 • Number of events 3
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Infections and infestations
Abdominal infection
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Infections and infestations
Colon infection
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Infections and infestations
Lung (pneumonia) infection
|
1.8%
2/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Infections and infestations
Penis infection
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Infections and infestations
Pneumonia
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Infections and infestations
Skin (cellulites) infection
|
0.91%
1/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Infections and infestations
Wound infection
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Injury, poisoning and procedural complications
Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
29.1%
32/110 • Number of events 65
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Alkaline phosphatase
|
25.5%
28/110 • Number of events 69
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Amylase
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
28.2%
31/110 • Number of events 55
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Blood bilirubin increased
|
20.0%
22/110 • Number of events 36
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Coagulation
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Creatinine
|
12.7%
14/110 • Number of events 29
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Lipase increased
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Metabolic/Lab
|
9.1%
10/110 • Number of events 12
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Platelet count decreased
|
0.91%
1/110 • Number of events 3
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Investigations
Weight loss
|
9.1%
10/110 • Number of events 10
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Bicarbonate
|
1.8%
2/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
21.8%
24/110 • Number of events 37
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
79.1%
87/110 • Number of events 279
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
22/110 • Number of events 31
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.4%
18/110 • Number of events 34
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.8%
2/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.6%
4/110 • Number of events 4
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.8%
2/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.5%
6/110 • Number of events 10
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.3%
8/110 • Number of events 11
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.5%
28/110 • Number of events 61
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower necrosis
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
2.7%
3/110 • Number of events 3
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
3/110 • Number of events 3
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Nervous system disorders
Cognitive disorder
|
0.91%
1/110 • Number of events 3
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Nervous system disorders
Headache
|
0.91%
1/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Nervous system disorders
Ischemia-Cerebral
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Nervous system disorders
Neuro
|
0.91%
1/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
30.0%
33/110 • Number of events 74
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Psychiatric disorders
Depression
|
0.91%
1/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Psychiatric disorders
Insomnia
|
1.8%
2/110 • Number of events 3
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Renal and urinary disorders
Pollakiuria
|
68.2%
75/110 • Number of events 171
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Renal and urinary disorders
Ureteral Obstruction
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Renal and urinary disorders
Urinary bladder hemorrhage
|
9.1%
10/110 • Number of events 11
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
21.8%
24/110 • Number of events 42
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Reproductive system and breast disorders
Breast pain
|
1.8%
2/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Reproductive system and breast disorders
Prostatic pain
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Reactions
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.8%
2/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.8%
2/110 • Number of events 3
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
0.91%
1/110 • Number of events 2
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
3/110 • Number of events 5
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
19.1%
21/110 • Number of events 29
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Vascular disorders
Flushing
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Vascular disorders
Hot flashes
|
80.0%
88/110 • Number of events 207
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
|
Vascular disorders
Hypertension
|
0.91%
1/110 • Number of events 1
Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place