Trial Outcomes & Findings for Phase II Hedgehog Inhibitor for Myelodysplastic Syndrome (MDS) (NCT NCT01842646)
NCT ID: NCT01842646
Last Updated: 2021-06-14
Results Overview
Response recorded from the start of the treatment until disease progression/recurrence. All responses must last for at least 8 weeks. Complete Remission (CR): Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines, Persistent dysplasia will be noted, Peripheral blood: Hemoglobin ≥ 11 g/dL, Platelets ≥ 100 x 10\^9/L, Neutrophils ≥ 1.0 x 10\^9/L, Blasts 0% ; Partial Remission (PR): All CR criteria if abnormal before treatment, except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still \> 5%, Cellularity and morphology not relevant; Marrow CR or Hematological Improvement (HI): Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment Peripheral blood: if HI responses, they will be noted in addition to marrow CR. Further investigation of PF-04449913 would not be warranted if it produced an overall response rate (CR + PR + marrow CR+HI) of 10% or less (p0), and would be warranted if it produced an overall response rate of 30% or more (p1).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Up to 2 years, 4 months
Results posted on
2021-06-14
Participant Flow
Recruitment began in August 2013 and participants were enrolled at Moffitt Cancer Center between September 2013 and September 2015.
Participant milestones
| Measure |
Experimental: PF-04449913 Treatment
Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Hedgehog Inhibitor for Myelodysplastic Syndrome (MDS)
Baseline characteristics by cohort
| Measure |
Experimental: PF-04449913 Treatment
n=35 Participants
Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=5 Participants
|
|
Age, Continuous
|
75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years, 4 monthsPopulation: All participants
Response recorded from the start of the treatment until disease progression/recurrence. All responses must last for at least 8 weeks. Complete Remission (CR): Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines, Persistent dysplasia will be noted, Peripheral blood: Hemoglobin ≥ 11 g/dL, Platelets ≥ 100 x 10\^9/L, Neutrophils ≥ 1.0 x 10\^9/L, Blasts 0% ; Partial Remission (PR): All CR criteria if abnormal before treatment, except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still \> 5%, Cellularity and morphology not relevant; Marrow CR or Hematological Improvement (HI): Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment Peripheral blood: if HI responses, they will be noted in addition to marrow CR. Further investigation of PF-04449913 would not be warranted if it produced an overall response rate (CR + PR + marrow CR+HI) of 10% or less (p0), and would be warranted if it produced an overall response rate of 30% or more (p1).
Outcome measures
| Measure |
Experimental: PF-04449913 Treatment
n=35 Participants
Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
|
|---|---|
|
Overall International Working Group (IWG) 2006 Response Rate
Complete Remission (CR)
|
0 Participants
|
|
Overall International Working Group (IWG) 2006 Response Rate
Hematological Improvement (HI)
|
2 Participants
|
|
Overall International Working Group (IWG) 2006 Response Rate
Stable Disease (SD)
|
19 Participants
|
|
Overall International Working Group (IWG) 2006 Response Rate
Progressive Disease (PD)
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years, 4 monthsPopulation: All participants
To estimate the overall survival of patients with refractory/relapsed myelodysplastic Syndrome (MDS) and chronic myelo-monocytic leukemia (CMML) treated with PF-0444913. Overall survival will be defined as the time period between the date of the first dose of drug until the time of death.
Outcome measures
| Measure |
Experimental: PF-04449913 Treatment
n=35 Participants
Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
|
|---|---|
|
Median Overall Survival (OS)
|
10.2 months
Interval 6.8 to 13.6
|
SECONDARY outcome
Timeframe: Up to 2 years, 4 monthsPopulation: All participants
To estimate the event-free survival of patients of this population. Event-free survival will be defined as the date of the first dose of study drug until failure (disease progression) or death from any cause.
Outcome measures
| Measure |
Experimental: PF-04449913 Treatment
n=35 Participants
Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
|
|---|---|
|
Median Event Free Survival
|
6.4 months
Interval 1.9 to 18.33
|
SECONDARY outcome
Timeframe: Up to 2 years, 4 monthsPopulation: NA- The median time to AML was not reached due to insufficient number of participants with events.
To estimate the time to transformation to AML in patients with \<20% blasts. In patients with less than 20% blasts, the time to transformation to AML will be defined as the date of the first dose of drug until either the percentage of bone marrow blasts or the percentage of peripheral blasts exceeds 20%, whichever is first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 years, 4 monthsPopulation: All participants
Treatment emergent adverse events occurring in equal to or more than 10% of participants.
Outcome measures
| Measure |
Experimental: PF-04449913 Treatment
n=35 Participants
Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Pain
|
22 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Dysgeusia
|
21 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Nausea
|
11 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Anorexia
|
11 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Skin/rash
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Oral mucositis
|
9 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : AST elevated
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Alopecia
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : ALT elevated
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Dizziness
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Dyspnea
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Infections
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Fatigue
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Diarrhea
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Constipation
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Fever
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Hyperkalemia
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Hyperglycemia
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Thrombocytopenia
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Headache
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 1-2 : Vomiting
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Pain
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Dysgeusia
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Nausea
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Anorexia
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Skin/rash
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Oral mucositis
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : AST elevated
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Alopecia
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : ALT elevated
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Dizziness
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Dyspnea
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Infections
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Fatigue
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Diarrhea
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Constipation
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Fever
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Hyperkalemia
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Hyperglycemia
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Thrombocytopenia
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Headache
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 : Vomiting
|
0 Participants
|
Adverse Events
Experimental: PF-04449913 Treatment
Serious events: 11 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: PF-04449913 Treatment
n=35 participants at risk
Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
1/35 • Number of events 2 • 2 years, 4 months
|
|
Cardiac disorders
Cardiac arrest
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Gastrointestinal disorders
Ileus
|
2.9%
1/35 • Number of events 2 • 2 years, 4 months
|
|
General disorders
Death NOS
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Infections and infestations
Abdominal infection
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Infections and infestations
Bone infection
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Infections and infestations
Infections and infestations - Other, GI
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Infections and infestations
Infections and infestations - Other, Rhinovirus/Enterovirus
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Infections and infestations
Lung infection
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Infections and infestations
Sepsis
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, possible DLBCL NHL
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
Other adverse events
| Measure |
Experimental: PF-04449913 Treatment
n=35 participants at risk
Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
|
|---|---|
|
General disorders
Pain
|
65.7%
23/35 • Number of events 30 • 2 years, 4 months
|
|
General disorders
Fatigue
|
17.1%
6/35 • Number of events 6 • 2 years, 4 months
|
|
General disorders
Fever
|
14.3%
5/35 • Number of events 5 • 2 years, 4 months
|
|
General disorders
Edema limbs
|
8.6%
3/35 • Number of events 3 • 2 years, 4 months
|
|
General disorders
Flu like symptoms
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
General disorders
Chills
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
General disorders
Gait disturbance
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
General disorders
General disorders and administration site conditions - Other
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
General disorders
Infusion related reaction
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Nervous system disorders
Dysgeusia
|
60.0%
21/35 • Number of events 25 • 2 years, 4 months
|
|
Nervous system disorders
Dizziness
|
17.1%
6/35 • Number of events 6 • 2 years, 4 months
|
|
Nervous system disorders
Headache
|
11.4%
4/35 • Number of events 5 • 2 years, 4 months
|
|
Nervous system disorders
Memory impairment
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Nervous system disorders
Tremor
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Nervous system disorders
Dysarthria
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Nervous system disorders
Dysphasia
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Nervous system disorders
Encephalopathy
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Nervous system disorders
Nervous system disorders - Other
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Investigations
Aspartate aminotransferase increased
|
22.9%
8/35 • Number of events 9 • 2 years, 4 months
|
|
Investigations
Alanine aminotransferase increased
|
17.1%
6/35 • Number of events 10 • 2 years, 4 months
|
|
Investigations
Weight loss
|
14.3%
5/35 • Number of events 5 • 2 years, 4 months
|
|
Investigations
Platelet count decreased
|
11.4%
4/35 • Number of events 6 • 2 years, 4 months
|
|
Investigations
Alkaline phosphatase increased
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Investigations
Creatinine increased
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Investigations
Neutrophil count decreased
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Investigations
Investigations - Other
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Anorexia
|
31.4%
11/35 • Number of events 14 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
5/35 • Number of events 6 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.4%
4/35 • Number of events 4 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.7%
2/35 • Number of events 3 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.7%
2/35 • Number of events 3 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/35 • Number of events 2 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.9%
1/35 • Number of events 2 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
1/35 • Number of events 4 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
2.9%
1/35 • Number of events 2 • 2 years, 4 months
|
|
Gastrointestinal disorders
Nausea
|
31.4%
11/35 • Number of events 13 • 2 years, 4 months
|
|
Gastrointestinal disorders
Mucositis oral
|
25.7%
9/35 • Number of events 9 • 2 years, 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
17.1%
6/35 • Number of events 6 • 2 years, 4 months
|
|
Gastrointestinal disorders
Constipation
|
14.3%
5/35 • Number of events 5 • 2 years, 4 months
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
4/35 • Number of events 4 • 2 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
5.7%
2/35 • Number of events 3 • 2 years, 4 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Gastrointestinal disorders
Periodontal disease
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Infections and infestations
Infections and infestations - Other
|
11.4%
4/35 • Number of events 7 • 2 years, 4 months
|
|
Infections and infestations
Skin infection
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Infections and infestations
Tooth infection
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Infections and infestations
Sinusitis
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.9%
8/35 • Number of events 8 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
14.3%
5/35 • Number of events 6 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
3/35 • Number of events 3 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.6%
3/35 • Number of events 3 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
Anemia
|
8.6%
3/35 • Number of events 4 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
3/35 • Number of events 3 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.1%
6/35 • Number of events 7 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.7%
2/35 • Number of events 4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Cardiac disorders
Chest pain - cardiac
|
5.7%
2/35 • Number of events 3 • 2 years, 4 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Psychiatric disorders
Confusion
|
5.7%
2/35 • Number of events 3 • 2 years, 4 months
|
|
Psychiatric disorders
Depression
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Vascular disorders
Flushing
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Vascular disorders
Hypertension
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Vascular disorders
Hypotension
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Vascular disorders
Lymphedema
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Injury, poisoning and procedural complications
Fall
|
5.7%
2/35 • Number of events 2 • 2 years, 4 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Eye disorders
Eye disorders - Other, specify
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Immune system disorders
Allergic reaction
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
|
Reproductive system and breast disorders
Testicular hemorrhage
|
2.9%
1/35 • Number of events 1 • 2 years, 4 months
|
Additional Information
Dr. Jeffrey Lancet
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-1387
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place