Trial Outcomes & Findings for Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma (NCT NCT01496807)
NCT ID: NCT01496807
Last Updated: 2017-04-28
Results Overview
MTD of peginterferon alfa-2b (Sylatron) combined with Ipilimumab (Yervoy).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Up to 48 Months
Results posted on
2017-04-28
Participant Flow
Between February 17, 2012 and December 5, 2013, 33 patients were screened and 31 patients were enrolled on treatment at Moffitt Cancer Center.
Participant milestones
| Measure |
Yervoy With Sylatron
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Yervoy With Sylatron
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
|
|---|---|
|
Overall Study
Progressive Disease
|
21
|
|
Overall Study
Participant preference/toxicity
|
8
|
|
Overall Study
Change in diagnosis
|
1
|
Baseline Characteristics
Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma
Baseline characteristics by cohort
| Measure |
Yervoy With Sylatron
n=31 Participants
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 MonthsPopulation: All participants
MTD of peginterferon alfa-2b (Sylatron) combined with Ipilimumab (Yervoy).
Outcome measures
| Measure |
Yervoy With Sylatron
n=31 Participants
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Sylatron
|
2 μg/kg s
|
PRIMARY outcome
Timeframe: Up to 48 MonthsPopulation: All participants
MTD of Ipilimumab (Yervoy) combined with peginterferon alfa-2b (Sylatron). To assess the safety, toxicities and tolerability of a regimen of 3 μg/kg weekly Sylatron with concurrent induction Yervoy at 3 mg/kg, then if well tolerated, at 10 mg/kg every three weeks four times, in participants with unresectable stages IIIC/IV melanoma, and to define a well tolerated dose of Yervoy in that combination.
Outcome measures
| Measure |
Yervoy With Sylatron
n=31 Participants
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Ipilimumab
|
3 mg/kg
|
SECONDARY outcome
Timeframe: Up to 54 MonthsPopulation: All evaluable participants
Overall Response: Complete Response (CR) + Partial Response (PR) by immune-related response criteria (irRC). Immune Related CR (irCR): Complete disappearance of all lesions (whether measurable or not, and no new lesions, and confirmation by a repeat consecutive assessment no less than 4 weeks from date first documented. Immure Related PR (irPR): decrease in tumor burden \>50% relative to baseline confirmed by repeat consecutive assessment at least 4 weeks later.
Outcome measures
| Measure |
Yervoy With Sylatron
n=30 Participants
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
|
|---|---|
|
Number of Participants With Overall Response (OR)
Complete Response
|
1 Participants
|
|
Number of Participants With Overall Response (OR)
Partial Response
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 54 MonthsPopulation: All evaluable participants
Immune Related Progressive Disease (irPD): increase in tumor burden \>25% relative to nadir (minimum recorded tumor burden) confirmed by repeat consecutive assessment at least 4 weeks later.
Outcome measures
| Measure |
Yervoy With Sylatron
n=30 Participants
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
|
|---|---|
|
Progression Free Survival (PFS)
|
5.9 months
Interval 2.8 to 11.2
|
SECONDARY outcome
Timeframe: Up to 54 MonthsPopulation: All evaluable participants
OS: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Outcome measures
| Measure |
Yervoy With Sylatron
n=30 Participants
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
|
|---|---|
|
Overall Survival (OS)
|
NA months
Interval 29.5 to
NA: The median overall survival was not reached in this study, with 18 patients (60%) alive at the time of censoring with a median follow-up of 35.8 months (range 19.7-50.2 months).
|
SECONDARY outcome
Timeframe: 4 Years, 1 MonthPopulation: All Participants
Percentage of participants with treatment related AEs, Grade 3 to 5. All adverse events, regardless of causality are also reported in the Serious Adverse Event/Other Adverse Event reporting area.
Outcome measures
| Measure |
Yervoy With Sylatron
n=31 Participants
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
|
|---|---|
|
Treatment Related Adverse Events (AEs) - Grade 3 to 5
Grade 4 Adverse Events
|
0 Participants
|
|
Treatment Related Adverse Events (AEs) - Grade 3 to 5
Grade 3 Adverse Events
|
15 Participants
|
|
Treatment Related Adverse Events (AEs) - Grade 3 to 5
Grade 5 Adverse Events
|
0 Participants
|
|
Treatment Related Adverse Events (AEs) - Grade 3 to 5
None Reported
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 54 MonthsPopulation: All evaluable participants
Number of participants who developed a positive result during treatment for one or more antibodies of a previously negative screen. This study was not designed to statistically test the efficacy of treatment, and no inferential analyses will be performed. Investigators planned to look for evidence of serologic and clinical autoimmunity.
Outcome measures
| Measure |
Yervoy With Sylatron
n=30 Participants
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
|
|---|---|
|
Count of Participants Developing Positive Autoantibody Screen
|
12 Participants
|
Adverse Events
Yervoy With Sylatron
Serious events: 14 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Yervoy With Sylatron
n=31 participants at risk
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Cardiac disorders
Myocardial infarction
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Endocrine disorders
Endocrine disorders - Other, hypopituitarism
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Endocrine disorders
Hypothyroidism
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Eye disorders
Blurred vision
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Gastrointestinal disorders
Colitis
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Gastrointestinal disorders
Diarrhea
|
9.7%
3/31 • Number of events 3 • 4 years, 1 month
|
|
Gastrointestinal disorders
Nausea
|
9.7%
3/31 • Number of events 3 • 4 years, 1 month
|
|
Gastrointestinal disorders
Vomiting
|
16.1%
5/31 • Number of events 5 • 4 years, 1 month
|
|
General disorders
Death NOS
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
General disorders
Fever
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
General disorders
Pain
|
6.5%
2/31 • Number of events 3 • 4 years, 1 month
|
|
Infections and infestations
Lung infection
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Infections and infestations
Sepsis
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Infections and infestations
Skin infection
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Nervous system disorders
Central nervous system necrosis
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Nervous system disorders
Facial nerve disorder
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Nervous system disorders
Memory impairment
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Nervous system disorders
Nervous system disorders - Other, Paresthesia
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Nervous system disorders
Stroke
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Nervous system disorders
Syncope
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Renal and urinary disorders
Urinary retention
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • Number of events 1 • 4 years, 1 month
|
Other adverse events
| Measure |
Yervoy With Sylatron
n=31 participants at risk
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
|
|---|---|
|
General disorders
Fatigue
|
93.5%
29/31 • Number of events 50 • 4 years, 1 month
|
|
General disorders
Chills
|
61.3%
19/31 • Number of events 24 • 4 years, 1 month
|
|
General disorders
Fever
|
48.4%
15/31 • Number of events 23 • 4 years, 1 month
|
|
General disorders
General disorders and administration site conditions - Other, Intermittent bleeding of gums
|
38.7%
12/31 • Number of events 18 • 4 years, 1 month
|
|
General disorders
General disorders and administration site conditions - Other, Increased appetite
|
38.7%
12/31 • Number of events 18 • 4 years, 1 month
|
|
General disorders
General disorders and administration site conditions - Other, Decreased appetite
|
38.7%
12/31 • Number of events 18 • 4 years, 1 month
|
|
General disorders
General disorders and administration site conditions - Other, Occasional chest tightness
|
38.7%
12/31 • Number of events 18 • 4 years, 1 month
|
|
General disorders
General disorders and administration site conditions - Other, Leg cramps
|
38.7%
12/31 • Number of events 18 • 4 years, 1 month
|
|
General disorders
General disorders and administration site conditions - Other, Cold sweats
|
38.7%
12/31 • Number of events 18 • 4 years, 1 month
|
|
General disorders
Flu like symptoms
|
25.8%
8/31 • Number of events 9 • 4 years, 1 month
|
|
General disorders
Injection site reaction
|
22.6%
7/31 • Number of events 7 • 4 years, 1 month
|
|
General disorders
Pain
|
19.4%
6/31 • Number of events 8 • 4 years, 1 month
|
|
General disorders
Infusion related reaction
|
9.7%
3/31 • Number of events 3 • 4 years, 1 month
|
|
General disorders
Malaise
|
9.7%
3/31 • Number of events 4 • 4 years, 1 month
|
|
General disorders
Non-cardiac chest pain
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Gastrointestinal disorders
Nausea
|
61.3%
19/31 • Number of events 36 • 4 years, 1 month
|
|
Gastrointestinal disorders
Diarrhea
|
58.1%
18/31 • Number of events 41 • 4 years, 1 month
|
|
Gastrointestinal disorders
Constipation
|
38.7%
12/31 • Number of events 13 • 4 years, 1 month
|
|
Gastrointestinal disorders
Vomiting
|
32.3%
10/31 • Number of events 17 • 4 years, 1 month
|
|
Gastrointestinal disorders
Abdominal pain
|
19.4%
6/31 • Number of events 6 • 4 years, 1 month
|
|
Gastrointestinal disorders
Dry mouth
|
16.1%
5/31 • Number of events 6 • 4 years, 1 month
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Mouth sores
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Gastrointestinal disorders
Colitis
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
2/31 • Number of events 3 • 4 years, 1 month
|
|
Gastrointestinal disorders
Flatulence
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Gastrointestinal disorders
Mucositis oral
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
83.9%
26/31 • Number of events 42 • 4 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
74.2%
23/31 • Number of events 45 • 4 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
25.8%
8/31 • Number of events 10 • 4 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.4%
6/31 • Number of events 6 • 4 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.9%
4/31 • Number of events 5 • 4 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.9%
4/31 • Number of events 9 • 4 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
9.7%
3/31 • Number of events 3 • 4 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Nervous system disorders
Headache
|
61.3%
19/31 • Number of events 30 • 4 years, 1 month
|
|
Nervous system disorders
Dizziness
|
29.0%
9/31 • Number of events 10 • 4 years, 1 month
|
|
Nervous system disorders
Dysgeusia
|
29.0%
9/31 • Number of events 9 • 4 years, 1 month
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Nervous system disorders
Tremor
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Metabolism and nutrition disorders
Anorexia
|
54.8%
17/31 • Number of events 21 • 4 years, 1 month
|
|
Metabolism and nutrition disorders
Dehydration
|
12.9%
4/31 • Number of events 5 • 4 years, 1 month
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.7%
3/31 • Number of events 4 • 4 years, 1 month
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.5%
2/31 • Number of events 6 • 4 years, 1 month
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.5%
2/31 • Number of events 5 • 4 years, 1 month
|
|
Investigations
White blood cell decreased
|
32.3%
10/31 • Number of events 26 • 4 years, 1 month
|
|
Investigations
Alanine aminotransferase increased
|
25.8%
8/31 • Number of events 9 • 4 years, 1 month
|
|
Investigations
Aspartate aminotransferase increased
|
25.8%
8/31 • Number of events 9 • 4 years, 1 month
|
|
Investigations
Neutrophil count decreased
|
19.4%
6/31 • Number of events 16 • 4 years, 1 month
|
|
Investigations
Platelet count decreased
|
19.4%
6/31 • Number of events 10 • 4 years, 1 month
|
|
Investigations
Lymphocyte count decreased
|
16.1%
5/31 • Number of events 14 • 4 years, 1 month
|
|
Investigations
Weight loss
|
16.1%
5/31 • Number of events 5 • 4 years, 1 month
|
|
Investigations
Alkaline phosphatase increased
|
6.5%
2/31 • Number of events 3 • 4 years, 1 month
|
|
Investigations
Creatinine increased
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
35.5%
11/31 • Number of events 15 • 4 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Temporomandibular joint pain
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Muscle spasms, Left side
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
35.5%
11/31 • Number of events 16 • 4 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.3%
10/31 • Number of events 14 • 4 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.9%
4/31 • Number of events 5 • 4 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.7%
3/31 • Number of events 3 • 4 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Eye disorders
Eye disorders - Other, Visual disturbance
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Eye disorders
Eye disorders - Other, Double vision
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Eye disorders
Eye disorders - Other, specify
|
22.6%
7/31 • Number of events 9 • 4 years, 1 month
|
|
Eye disorders
Blurred vision
|
9.7%
3/31 • Number of events 3 • 4 years, 1 month
|
|
Eye disorders
Dry eye
|
9.7%
3/31 • Number of events 3 • 4 years, 1 month
|
|
Psychiatric disorders
Anxiety
|
19.4%
6/31 • Number of events 7 • 4 years, 1 month
|
|
Psychiatric disorders
Depression
|
19.4%
6/31 • Number of events 8 • 4 years, 1 month
|
|
Psychiatric disorders
Confusion
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Psychiatric disorders
Insomnia
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Endocrine disorders
Endocrine disorders - Other, Night sweats
|
12.9%
4/31 • Number of events 6 • 4 years, 1 month
|
|
Blood and lymphatic system disorders
Anemia
|
19.4%
6/31 • Number of events 15 • 4 years, 1 month
|
|
Ear and labyrinth disorders
Hearing impaired
|
9.7%
3/31 • Number of events 3 • 4 years, 1 month
|
|
Ear and labyrinth disorders
Vertigo
|
9.7%
3/31 • Number of events 3 • 4 years, 1 month
|
|
Infections and infestations
Urinary tract infection
|
12.9%
4/31 • Number of events 9 • 4 years, 1 month
|
|
Vascular disorders
Hypertension
|
9.7%
3/31 • Number of events 6 • 4 years, 1 month
|
|
Vascular disorders
Hot flashes
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Reproductive system and breast disorders
Breast pain
|
6.5%
2/31 • Number of events 2 • 4 years, 1 month
|
|
Renal and urinary disorders
Urinary frequency
|
6.5%
2/31 • Number of events 3 • 4 years, 1 month
|
|
Injury, poisoning and procedural complications
Fall
|
6.5%
2/31 • Number of events 3 • 4 years, 1 month
|
Additional Information
Dr. Andrew Brohl
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3242
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place