Trial Outcomes & Findings for Ipilimumab With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Melanoma Mets Pts (NCT NCT01701674)
NCT ID: NCT01701674
Last Updated: 2025-12-19
Results Overview
Occurrence of adverse events with dose limiting toxicity, per adverse event category.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
3 months
Results posted on
2025-12-19
Participant Flow
Participants were enrolled at Moffitt Cancer Center, April 2013 through July 2014.
Participant milestones
| Measure |
Experimental: Combination Therapy
The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Experimental: Combination Therapy
The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
|
|---|---|
|
Overall Study
Unable to safely complete treatment
|
1
|
Baseline Characteristics
Ipilimumab With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Melanoma Mets Pts
Baseline characteristics by cohort
| Measure |
Experimental: Combination Therapy
n=13 Participants
The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=8 Participants
|
|
Age, Continuous
|
49 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All participants
Occurrence of adverse events with dose limiting toxicity, per adverse event category.
Outcome measures
| Measure |
Experimental: Combination Therapy
n=13 Participants
The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
|
|---|---|
|
Occurrence of Dose Limiting Toxicity (DLT) Events
Eye-related: Uveitis
|
1 DLT events
|
|
Occurrence of Dose Limiting Toxicity (DLT) Events
Gastrointestinal: Colitis
|
1 DLT events
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All participants
Number of participants who were successfully treated with at least 2 doses of ipilimumab and received TIL. Feasibility is defined as the ability to deliver at least 50% (i.e., two out of four) of the planned doses of ipilimumab and successfully treat at least 60% (i.e., ≥ 6/10) of the patients with TIL.
Outcome measures
| Measure |
Experimental: Combination Therapy
n=13 Participants
The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
|
|---|---|
|
Rate of Meeting Feasibility Requirements
|
12 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All participants.
Overall Response: Complete Response (CR) + Partial Response (PR), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by computed tomography (CT) scan. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions..
Outcome measures
| Measure |
Experimental: Combination Therapy
n=13 Participants
The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
|
|---|---|
|
Overall Response Rate (ORR)
|
38.5 percentage of participants
|
SECONDARY outcome
Timeframe: 42 monthsPopulation: All participants.
Progression-free survival (PFS) per RECIST V1.1, defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Progressive Disease (PD): At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Experimental: Combination Therapy
n=13 Participants
The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
|
|---|---|
|
Progression Free Survival (PFS)
|
7.4 months
Interval 1.5 to 42.0
|
Adverse Events
Experimental: Combination Therapy
Serious events: 9 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Combination Therapy
n=13 participants at risk
The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
|
|---|---|
|
Endocrine disorders
Hypothyroidism
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Eye disorders
Uveitis
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Colonic perforation
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Immune system disorders
Autoimmune disorder
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Infections and infestations
Abdominal infection
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Infections and infestations
Appendicitis
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Infections and infestations
Catheter related infection
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Injury, poisoning and procedural complications
Fracture
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Investigations
Investigations - Other, SIADH
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Nervous system disorders
Presyncope
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Renal and urinary disorders
Cystitis non-infective
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Cistitis infective
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
Other adverse events
| Measure |
Experimental: Combination Therapy
n=13 participants at risk
The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
38.5%
5/13 • Number of events 6 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
53.8%
7/13 • Number of events 9 • 3 years, 6 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Vascular disorders
Capillary leak syndrome
|
30.8%
4/13 • Number of events 4 • 3 years, 6 months
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Vascular disorders
Hot flashes
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Number of events 2 • 3 years, 6 months
|
|
Vascular disorders
Hypotension
|
69.2%
9/13 • Number of events 14 • 3 years, 6 months
|
|
Vascular disorders
Lymphedema
|
23.1%
3/13 • Number of events 3 • 3 years, 6 months
|
|
Vascular disorders
Vascular disorders - Other
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
23.1%
3/13 • Number of events 4 • 3 years, 6 months
|
|
Investigations
Alanine aminotransferase increased
|
84.6%
11/13 • Number of events 24 • 3 years, 6 months
|
|
Investigations
Alkaline phosphatase increased
|
69.2%
9/13 • Number of events 18 • 3 years, 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
92.3%
12/13 • Number of events 26 • 3 years, 6 months
|
|
Investigations
Blood bilirubin increased
|
38.5%
5/13 • Number of events 11 • 3 years, 6 months
|
|
Investigations
Cardiac troponin T increased
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Investigations
CPK increased
|
46.2%
6/13 • Number of events 9 • 3 years, 6 months
|
|
Investigations
Creatinine increased
|
23.1%
3/13 • Number of events 5 • 3 years, 6 months
|
|
Investigations
INR increased
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Investigations
Investigations - Other
|
15.4%
2/13 • Number of events 7 • 3 years, 6 months
|
|
Investigations
Lipase increased
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Investigations
Lymphocyte count decreased
|
92.3%
12/13 • Number of events 45 • 3 years, 6 months
|
|
Investigations
Lymphocyte count increased
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Investigations
Neutrophil count decreased
|
92.3%
12/13 • Number of events 32 • 3 years, 6 months
|
|
Investigations
Platelet count decreased
|
92.3%
12/13 • Number of events 61 • 3 years, 6 months
|
|
Investigations
Serum amylase increased
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Investigations
Weight gain
|
7.7%
1/13 • Number of events 4 • 3 years, 6 months
|
|
Investigations
White blood cell decreased
|
92.3%
12/13 • Number of events 49 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Acidosis
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
61.5%
8/13 • Number of events 10 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.7%
1/13 • Number of events 2 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.4%
2/13 • Number of events 9 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
30.8%
4/13 • Number of events 7 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
92.3%
12/13 • Number of events 37 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.1%
3/13 • Number of events 8 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.1%
3/13 • Number of events 3 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
30.8%
4/13 • Number of events 7 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
76.9%
10/13 • Number of events 32 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
92.3%
12/13 • Number of events 21 • 3 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.1%
3/13 • Number of events 4 • 3 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.7%
1/13 • Number of events 3 • 3 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
38.5%
5/13 • Number of events 6 • 3 years, 6 months
|
|
Gastrointestinal disorders
Mucositis oral
|
30.8%
4/13 • Number of events 6 • 3 years, 6 months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
13/13 • Number of events 31 • 3 years, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
69.2%
9/13 • Number of events 11 • 3 years, 6 months
|
|
General disorders
Chills
|
76.9%
10/13 • Number of events 16 • 3 years, 6 months
|
|
General disorders
Edema limbs
|
38.5%
5/13 • Number of events 8 • 3 years, 6 months
|
|
General disorders
Fatigue
|
84.6%
11/13 • Number of events 33 • 3 years, 6 months
|
|
General disorders
Fever
|
53.8%
7/13 • Number of events 12 • 3 years, 6 months
|
|
General disorders
Flu like symptoms
|
23.1%
3/13 • Number of events 4 • 3 years, 6 months
|
|
General disorders
General disorders and administration site conditions - Other
|
53.8%
7/13 • Number of events 15 • 3 years, 6 months
|
|
General disorders
Localized edema
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
General disorders
Malaise
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
General disorders
Non-cardiac chest pain
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
General disorders
Pain
|
53.8%
7/13 • Number of events 13 • 3 years, 6 months
|
|
Immune system disorders
Allergic reaction
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Immune system disorders
Immune system disorders - Other
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Infections and infestations
Bronchial infection
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Infections and infestations
Infections and infestations - Other
|
38.5%
5/13 • Number of events 5 • 3 years, 6 months
|
|
Infections and infestations
Mucosal infection
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Infections and infestations
Penile infection
|
7.7%
1/13 • Number of events 2 • 3 years, 6 months
|
|
Infections and infestations
Upper respiratory infection
|
23.1%
3/13 • Number of events 3 • 3 years, 6 months
|
|
Infections and infestations
Urinary tract infection
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Infections and infestations
Wound infection
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Injury, poisoning and procedural complications
Bruising
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • Number of events 2 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.5%
5/13 • Number of events 7 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.1%
3/13 • Number of events 3 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
15.4%
2/13 • Number of events 3 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
61.5%
8/13 • Number of events 18 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
61.5%
8/13 • Number of events 22 • 3 years, 6 months
|
|
Cardiac disorders
Sinus bradycardia
|
7.7%
1/13 • Number of events 2 • 3 years, 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
69.2%
9/13 • Number of events 12 • 3 years, 6 months
|
|
Cardiac disorders
Ventricular tachycardia
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Endocrine disorders
Endocrine disorders - Other
|
23.1%
3/13 • Number of events 4 • 3 years, 6 months
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
1/13 • Number of events 2 • 3 years, 6 months
|
|
Eye disorders
Blurred vision
|
23.1%
3/13 • Number of events 3 • 3 years, 6 months
|
|
Eye disorders
Cataract
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Eye disorders
Conjunctivitis
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Eye disorders
Dry eye
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Eye disorders
Eye disorders - Other
|
23.1%
3/13 • Number of events 4 • 3 years, 6 months
|
|
Eye disorders
Eye pain
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Eye disorders
Uveitis
|
7.7%
1/13 • Number of events 2 • 3 years, 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
38.5%
5/13 • Number of events 8 • 3 years, 6 months
|
|
Gastrointestinal disorders
Bloating
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Gastrointestinal disorders
Colitis
|
15.4%
2/13 • Number of events 3 • 3 years, 6 months
|
|
Gastrointestinal disorders
Constipation
|
53.8%
7/13 • Number of events 10 • 3 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
84.6%
11/13 • Number of events 30 • 3 years, 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
92.3%
12/13 • Number of events 82 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
76.9%
10/13 • Number of events 10 • 3 years, 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Cardiac disorders
Cardiac disorders - Other
|
23.1%
3/13 • Number of events 4 • 3 years, 6 months
|
|
Cardiac disorders
Palpitations
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
23.1%
3/13 • Number of events 4 • 3 years, 6 months
|
|
Nervous system disorders
Dizziness
|
53.8%
7/13 • Number of events 10 • 3 years, 6 months
|
|
Nervous system disorders
Dysarthria
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Nervous system disorders
Dysgeusia
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Nervous system disorders
Headache
|
76.9%
10/13 • Number of events 12 • 3 years, 6 months
|
|
Nervous system disorders
Nervous system disorders - Other
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Nervous system disorders
Paresthesia
|
23.1%
3/13 • Number of events 3 • 3 years, 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Nervous system disorders
Somnolence
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Psychiatric disorders
Agitation
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Psychiatric disorders
Insomnia
|
23.1%
3/13 • Number of events 4 • 3 years, 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
7.7%
1/13 • Number of events 2 • 3 years, 6 months
|
|
Renal and urinary disorders
Bladder spasm
|
7.7%
1/13 • Number of events 2 • 3 years, 6 months
|
|
Renal and urinary disorders
Cystitis non-infective
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Renal and urinary disorders
Hematuria
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
7.7%
1/13 • Number of events 4 • 3 years, 6 months
|
|
Renal and urinary disorders
Urinary frequency
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Renal and urinary disorders
Urinary tract pain
|
7.7%
1/13 • Number of events 2 • 3 years, 6 months
|
|
Renal and urinary disorders
Urine discoloration
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Reproductive system and breast disorders
Scrotal pain
|
7.7%
1/13 • Number of events 3 • 3 years, 6 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
15.4%
2/13 • Number of events 3 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
61.5%
8/13 • Number of events 12 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
76.9%
10/13 • Number of events 18 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
23.1%
3/13 • Number of events 3 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
15.4%
2/13 • Number of events 2 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
7.7%
1/13 • Number of events 1 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
15.4%
2/13 • Number of events 3 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
38.5%
5/13 • Number of events 7 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
30.8%
4/13 • Number of events 4 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
23.1%
3/13 • Number of events 4 • 3 years, 6 months
|
Additional Information
Dr. Amod Sarnaik
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-8581
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place