Trial Outcomes & Findings for Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma (NCT NCT01005745)
NCT ID: NCT01005745
Last Updated: 2025-12-19
Results Overview
Feasibility was the primary endpoint of this trial, defined as a patient who can grow and expand T-cells: Number of participants with fragments cultured; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture and were cocultured with autologous or human leukocyte antigen (HLA)-matched tumor cells for interferon(IFN)-γ production; Number of participants with fragments that produced IFN-γ in response to autologous or HLA-matched tumor cells.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
192 Days Post Surgical Resection
Results posted on
2025-12-19
Participant Flow
Participants were recruited at Moffitt Cancer Center from October 20, 2009 until November 15, 2012.
Participant milestones
| Measure |
TIL With High Dose IL-2
Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.
Day -5 to Day -1: Fludarabine 25 mg/m\^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.
Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.
Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Surgery: Surgery to remove a tumor for growth of TIL
Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
Adoptive Cell Transfer: T-cell infusion
High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
TIL With High Dose IL-2
Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.
Day -5 to Day -1: Fludarabine 25 mg/m\^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.
Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.
Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Surgery: Surgery to remove a tumor for growth of TIL
Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
Adoptive Cell Transfer: T-cell infusion
High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion.
|
|---|---|
|
Overall Study
No TIL growth
|
1
|
|
Overall Study
Disease progressed during TIL growth
|
3
|
|
Overall Study
Death prior to treatment
|
1
|
|
Overall Study
Inappropriate antidiuretic hormone
|
1
|
Baseline Characteristics
Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
TIL With High Dose IL-2
n=19 Participants
Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.
Day -5 to Day -1: Fludarabine 25 mg/m\^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.
Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.
Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Surgery: Surgery to remove a tumor for growth of TIL
Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
Adoptive Cell Transfer: T-cell infusion
High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion.
|
|---|---|
|
Age, Continuous
|
46.5 years
n=8 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 192 Days Post Surgical ResectionPopulation: All participants
Feasibility was the primary endpoint of this trial, defined as a patient who can grow and expand T-cells: Number of participants with fragments cultured; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture and were cocultured with autologous or human leukocyte antigen (HLA)-matched tumor cells for interferon(IFN)-γ production; Number of participants with fragments that produced IFN-γ in response to autologous or HLA-matched tumor cells.
Outcome measures
| Measure |
TIL With High Dose IL-2
n=19 Participants
Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.
Day -5 to Day -1: Fludarabine 25 mg/m\^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.
Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.
Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Surgery: Surgery to remove a tumor for growth of TIL
Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
Adoptive Cell Transfer: T-cell infusion
High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion.
|
|---|---|
|
Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth
Participants with fragments cultured
|
19 participants
|
|
Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth
Participants with fragments grown
|
14 participants
|
|
Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth
Participants with fragments tested
|
14 participants
|
|
Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth
Participants with IFN-γ positive fragments
|
13 participants
|
SECONDARY outcome
Timeframe: Average of 10 Months Follow-upPopulation: All participants who completed treatment
OR is defined as the patient being alive at Day 70 and tumor size evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be a complete response or partial response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Evaluations were made by computed tomography (CT) scan approximately 6 to 8 weeks after the cell infusion, or CT scan approximately 10 weeks after the cell infusion, or by clinical evaluation during the first 70 days.
Outcome measures
| Measure |
TIL With High Dose IL-2
n=13 Participants
Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.
Day -5 to Day -1: Fludarabine 25 mg/m\^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.
Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.
Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Surgery: Surgery to remove a tumor for growth of TIL
Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
Adoptive Cell Transfer: T-cell infusion
High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion.
|
|---|---|
|
Number of Participants With Objective Response (OR)
Complete Response (CR)
|
2 participants
|
|
Number of Participants With Objective Response (OR)
Complete Response (PR + CR)
|
5 participants
|
|
Number of Participants With Objective Response (OR)
Partial Response (PR)
|
3 participants
|
Adverse Events
TIL With High Dose IL-2
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TIL With High Dose IL-2
n=19 participants at risk
Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.
Day -5 to Day -1: Fludarabine 25 mg/m\^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.
Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.
Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Surgery: Surgery to remove a tumor for growth of TIL
Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
Adoptive Cell Transfer: T-cell infusion
High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Eye disorders
Cataract
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Eye disorders
Uveitis
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • Number of events 3 • 3 years
All participants
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
General disorders
Fever
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Infections and infestations
Bladder infection
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Investigations
Blood antidiuretic hormone abnormal
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Investigations
Urine output decreased
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other - basal cell carcinoma
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Invasive squamous cell
|
5.3%
1/19 • Number of events 2 • 3 years
All participants
|
|
Renal and urinary disorders
Acute kidney injury
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Renal and urinary disorders
Cystitis noninfective
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other - pulmonary edema
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
Other adverse events
| Measure |
TIL With High Dose IL-2
n=19 participants at risk
Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.
Day -5 to Day -1: Fludarabine 25 mg/m\^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.
Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.
Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Surgery: Surgery to remove a tumor for growth of TIL
Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
Adoptive Cell Transfer: T-cell infusion
High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion.
|
|---|---|
|
General disorders
Fatigue
|
73.7%
14/19 • Number of events 32 • 3 years
All participants
|
|
General disorders
Chills
|
68.4%
13/19 • Number of events 17 • 3 years
All participants
|
|
General disorders
Edema - limbs
|
26.3%
5/19 • Number of events 9 • 3 years
All participants
|
|
Gastrointestinal disorders
General disorders and administration site - Other
|
15.8%
3/19 • Number of events 4 • 3 years
All participants
|
|
General disorders
Pain
|
15.8%
3/19 • Number of events 3 • 3 years
All participants
|
|
General disorders
Fever
|
10.5%
2/19 • Number of events 3 • 3 years
All participants
|
|
General disorders
Edema - trunk
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Investigations
Platelet count decreased
|
68.4%
13/19 • Number of events 84 • 3 years
All participants
|
|
Investigations
White blood cell decreased
|
68.4%
13/19 • Number of events 52 • 3 years
All participants
|
|
Investigations
Alkaline phosphatase increased
|
52.6%
10/19 • Number of events 19 • 3 years
All participants
|
|
Investigations
Blood bilirubin increased
|
52.6%
10/19 • Number of events 23 • 3 years
All participants
|
|
Investigations
Alanine aminotransferase increased
|
42.1%
8/19 • Number of events 11 • 3 years
All participants
|
|
Investigations
Creatinine increased
|
42.1%
8/19 • Number of events 13 • 3 years
All participants
|
|
Investigations
Lymphocyte count decreased
|
42.1%
8/19 • Number of events 27 • 3 years
All participants
|
|
Investigations
Aspartate aminotransferase increased
|
36.8%
7/19 • Number of events 12 • 3 years
All participants
|
|
Investigations
Neutrophil count decreased
|
36.8%
7/19 • Number of events 22 • 3 years
All participants
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Investigations
Blood antidiuretic hormone abnormal
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Investigations
Investigations - Other
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Investigations
Urine output decreased
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Hyponatremia
|
68.4%
13/19 • Number of events 29 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
63.2%
12/19 • Number of events 43 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
63.2%
12/19 • Number of events 23 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Anorexia
|
52.6%
10/19 • Number of events 13 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
52.6%
10/19 • Number of events 42 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
47.4%
9/19 • Number of events 25 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
47.4%
9/19 • Number of events 17 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.1%
4/19 • Number of events 7 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
15.8%
3/19 • Number of events 3 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
15.8%
3/19 • Number of events 5 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Acidosis
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Blood and lymphatic system disorders
Anemia
|
68.4%
13/19 • Number of events 71 • 3 years
All participants
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
47.4%
9/19 • Number of events 9 • 3 years
All participants
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
36.8%
7/19 • Number of events 24 • 3 years
All participants
|
|
Cardiac disorders
Sinus tachycardia
|
52.6%
10/19 • Number of events 14 • 3 years
All participants
|
|
Cardiac disorders
Atrial fibrillation
|
15.8%
3/19 • Number of events 3 • 3 years
All participants
|
|
Cardiac disorders
Cardiac disorders - Other
|
15.8%
3/19 • Number of events 4 • 3 years
All participants
|
|
Cardiac disorders
Chest pain - cardiac
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Cardiac disorders
Myocarditis
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Cardiac disorders
Sinus bradycardia
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Gastrointestinal disorders
Nausea
|
68.4%
13/19 • Number of events 19 • 3 years
All participants
|
|
Gastrointestinal disorders
Vomiting
|
52.6%
10/19 • Number of events 15 • 3 years
All participants
|
|
Gastrointestinal disorders
Diarrhea
|
47.4%
9/19 • Number of events 12 • 3 years
All participants
|
|
Gastrointestinal disorders
Constipation
|
15.8%
3/19 • Number of events 5 • 3 years
All participants
|
|
Gastrointestinal disorders
Mucositis oral
|
15.8%
3/19 • Number of events 4 • 3 years
All participants
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Gastrointestinal disorders
Anal hemorrhage
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Gastrointestinal disorders
Gastroparesis
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
47.4%
9/19 • Number of events 10 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
26.3%
5/19 • Number of events 5 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
21.1%
4/19 • Number of events 5 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
21.1%
4/19 • Number of events 4 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.8%
3/19 • Number of events 3 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
15.8%
3/19 • Number of events 3 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
15.8%
3/19 • Number of events 3 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Vascular disorders
Hypotension
|
47.4%
9/19 • Number of events 9 • 3 years
All participants
|
|
Vascular disorders
Capillary leak syndrome
|
21.1%
4/19 • Number of events 4 • 3 years
All participants
|
|
Vascular disorders
Vascular disorders - Other
|
21.1%
4/19 • Number of events 5 • 3 years
All participants
|
|
Vascular disorders
Flushing
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
|
Vascular disorders
Hot flashes
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Nervous system disorders
Headache
|
26.3%
5/19 • Number of events 7 • 3 years
All participants
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
|
Nervous system disorders
Cognitive disturbance
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Nervous system disorders
Depressed level of consciousness
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Nervous system disorders
Dysgeusia
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Nervous system disorders
Encephalopathy
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Nervous system disorders
Sinus pain
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Nervous system disorders
Syncope
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Nervous system disorders
Vasovagal reaction
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.6%
6/19 • Number of events 6 • 3 years
All participants
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
26.3%
5/19 • Number of events 5 • 3 years
All participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.8%
3/19 • Number of events 3 • 3 years
All participants
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
15.8%
3/19 • Number of events 4 • 3 years
All participants
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Psychiatric disorders
Confusion
|
21.1%
4/19 • Number of events 6 • 3 years
All participants
|
|
Psychiatric disorders
Anxiety
|
15.8%
3/19 • Number of events 3 • 3 years
All participants
|
|
Psychiatric disorders
Insomnia
|
15.8%
3/19 • Number of events 3 • 3 years
All participants
|
|
Psychiatric disorders
Depression
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
|
Psychiatric disorders
Delirium
|
5.3%
1/19 • Number of events 3 • 3 years
All participants
|
|
Renal and urinary disorders
Acute kidney injury
|
15.8%
3/19 • Number of events 8 • 3 years
All participants
|
|
Renal and urinary disorders
Urinary retention
|
15.8%
3/19 • Number of events 3 • 3 years
All participants
|
|
Renal and urinary disorders
Proteinuria
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
|
Renal and urinary disorders
Bladder spasm
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Renal and urinary disorders
Cystitis noninfective
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Renal and urinary disorders
Hematuria
|
5.3%
1/19 • Number of events 3 • 3 years
All participants
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
5.3%
1/19 • Number of events 2 • 3 years
All participants
|
|
Renal and urinary disorders
Urinary frequency
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Renal and urinary disorders
Urinary incontinence
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Renal and urinary disorders
Urinary tract pain
|
5.3%
1/19 • Number of events 2 • 3 years
All participants
|
|
Renal and urinary disorders
Urine discoloration
|
5.3%
1/19 • Number of events 2 • 3 years
All participants
|
|
Immune system disorders
Cytokine release syndrome
|
15.8%
3/19 • Number of events 3 • 3 years
All participants
|
|
Immune system disorders
Immune system disorders - Other
|
15.8%
3/19 • Number of events 4 • 3 years
All participants
|
|
Eye disorders
Blurred vision
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
|
Eye disorders
Flashing lights
|
10.5%
2/19 • Number of events 3 • 3 years
All participants
|
|
Eye disorders
Cataract
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Eye disorders
Photophobia
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Eye disorders
Uveitis
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Ear and labyrinth disorders
Tinnitus
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Ear and labyrinth disorders
Vertigo
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Infections and infestations
Bladder infection
|
5.3%
1/19 • Number of events 1 • 3 years
All participants
|
|
Infections and infestations
Skin infection
|
5.3%
1/19 • Number of events 3 • 3 years
All participants
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
10.5%
2/19 • Number of events 2 • 3 years
All participants
|
Additional Information
Amod Sarnaik, M.D.
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