Trial Outcomes & Findings for Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies (NCT NCT01341301)
NCT ID: NCT01341301
Last Updated: 2025-04-30
Results Overview
To assess relapse free survival in participants undergoing Hematopoietic Stem Cell Transplant (HSCT) using the Thomas Jefferson University 2 step approach with an extra day inserted between the donor lymphocyte infusion (DLI) and administration of cyclophosphamide.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
1 year after undergoing hematopoietic stem cell transplant
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
Allogeneic HSCT
CONDITIONING: Patients undergo total body irradiation (TBI) twice daily (BID) on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients receive Donor Lymphocyte Infusion (DLI) on day -6 and undergo cluster of differentiation (CD34+) selected allogeneic HSCT on day 0
Graft-versus-host disease (GVHD) PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.
Total Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Tacrolimus: Given IV or PO
Mycophenolate mofetil: Given IV or PO
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
Laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Allogeneic HSCT
n=25 Participants
CONDITIONING: Patients undergo TBI BID on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients receive DLI on day -6 and undergo CD34+ selected allogeneic HSCT on day 0
GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.
Total Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Tacrolimus: Given IV or PO
Mycophenolate mofetil: Given IV or PO
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
Laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year after undergoing hematopoietic stem cell transplantTo assess relapse free survival in participants undergoing Hematopoietic Stem Cell Transplant (HSCT) using the Thomas Jefferson University 2 step approach with an extra day inserted between the donor lymphocyte infusion (DLI) and administration of cyclophosphamide.
Outcome measures
| Measure |
Allogeneic HSCT
n=25 Participants
CONDITIONING: Patients undergo TBI BID on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients receive DLI on day -6 and undergo CD34+ selected allogeneic HSCT on day 0
GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.
Total Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Tacrolimus: Given IV or PO
Mycophenolate mofetil: Given IV or PO
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
Laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Participants That Experience One Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplant (HSCT)
|
5 Participants
|
SECONDARY outcome
Timeframe: Assessed up to 1 yearPopulation: Data were not collected
Reported descriptively
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed up to 1 yearPopulation: Data were not collected
Reported descriptively
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed up to 1 yearPopulation: Data were not collected
Reported descriptively
Outcome measures
Outcome data not reported
Adverse Events
Allogeneic HSCT
Serious events: 25 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Allogeneic HSCT
n=25 participants at risk
CONDITIONING: Patients undergo TBI BID on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients receive DLI on day -6 and undergo CD34+ selected allogeneic HSCT on day 0
GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.
Total Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Tacrolimus: Given IV or PO
Mycophenolate mofetil: Given IV or PO
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
Laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Acute renal failure
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
Agitation
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Cholecystitis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
CMV colitis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
CMV reactivation
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Depression
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Elevated liver enzymes
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Fevers
|
8.0%
2/25 • Number of events 3 • 1 year
|
|
Blood and lymphatic system disorders
Hematuria
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Cardiac disorders
Hypotension
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hypoxia
|
16.0%
4/25 • Number of events 6 • 1 year
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Reintubation
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disease
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Infections and infestations
Sepsis
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Syncope
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Volume overload
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Weight gain
|
4.0%
1/25 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Allogeneic HSCT
n=25 participants at risk
CONDITIONING: Patients undergo TBI BID on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients receive DLI on day -6 and undergo CD34+ selected allogeneic HSCT on day 0
GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.
Total Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Tacrolimus: Given IV or PO
Mycophenolate mofetil: Given IV or PO
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
Laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Abdominal discomfort
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
32.0%
8/25 • Number of events 10 • 1 year
|
|
Renal and urinary disorders
Abnormal LFTs
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
16.0%
4/25 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Agitation
|
20.0%
5/25 • Number of events 5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Ankle pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Anxiety
|
32.0%
8/25 • Number of events 9 • 1 year
|
|
Nervous system disorders
Aphasia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arm pain
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arm swelling
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Arthritis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
5/25 • Number of events 6 • 1 year
|
|
Blood and lymphatic system disorders
Bacteremia
|
12.0%
3/25 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Benign prostatic hyperplasia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Infections and infestations
BK viremia
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Eye disorders
Black eye
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Blister
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Blood-tinged sputum
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Eye disorders
Blurry vision
|
8.0%
2/25 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.0%
2/25 • Number of events 3 • 1 year
|
|
Cardiac disorders
Bradycardia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Calf pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Eye disorders
Change in vision
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Chest discomfort
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
General disorders
Chest pain
|
20.0%
5/25 • Number of events 5 • 1 year
|
|
General disorders
Chills/rigors
|
40.0%
10/25 • Number of events 12 • 1 year
|
|
Gastrointestinal disorders
Clostridium difficile
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
CMV reactivation
|
20.0%
5/25 • Number of events 5 • 1 year
|
|
Infections and infestations
CMV viremia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Confusion
|
20.0%
5/25 • Number of events 5 • 1 year
|
|
General disorders
Congestion
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
28.0%
7/25 • Number of events 7 • 1 year
|
|
General disorders
Cough
|
32.0%
8/25 • Number of events 9 • 1 year
|
|
General disorders
Crackles
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Cystitis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
5/25 • Number of events 5 • 1 year
|
|
Renal and urinary disorders
Decreased urine output
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Cardiac disorders
Deep vein thrombosis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Nervous system disorders
Depression
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Diaphoresis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
15/25 • Number of events 21 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Difficulty hearing
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Dizziness
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Dry mouth
|
16.0%
4/25 • Number of events 4 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Cardiac disorders
Dysarthria
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Dysgeusia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Dysphagia
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.0%
4/25 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Dysuria
|
16.0%
4/25 • Number of events 4 • 1 year
|
|
General disorders
Edema
|
48.0%
12/25 • Number of events 16 • 1 year
|
|
General disorders
Electrolyte imbalance
|
24.0%
6/25 • Number of events 8 • 1 year
|
|
General disorders
Elevated alkaline phosphatase
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Elevated liver enzymes
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Epigastric pain
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
Epistaxis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Esophagitis
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Eye disorders
Eye dryness
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Eye disorders
Eye pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Facial pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
36.0%
9/25 • Number of events 10 • 1 year
|
|
General disorders
Feet/ankle swelling
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
Fevers
|
68.0%
17/25 • Number of events 30 • 1 year
|
|
General disorders
Flank pain
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Gas pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
General pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Hallucinations
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
Hand/foot tightness
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Headache
|
48.0%
12/25 • Number of events 17 • 1 year
|
|
Blood and lymphatic system disorders
Hematoma
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
20.0%
5/25 • Number of events 5 • 1 year
|
|
Blood and lymphatic system disorders
Hemochromatosis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hernia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Infections and infestations
HHV6 viremia
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
General disorders
Hiccups
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
Hip pain
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
Hives
|
16.0%
4/25 • Number of events 4 • 1 year
|
|
General disorders
Hoarseness
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
32.0%
8/25 • Number of events 8 • 1 year
|
|
Blood and lymphatic system disorders
Hypercholesterolemia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hives
|
16.0%
4/25 • Number of events 4 • 1 year
|
|
General disorders
Hyperglycemia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Hyperkalemia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hypernatremia
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
Hypertension
|
40.0%
10/25 • Number of events 12 • 1 year
|
|
General disorders
Hypervolemia
|
20.0%
5/25 • Number of events 5 • 1 year
|
|
General disorders
Hypokalemia
|
8.0%
2/25 • Number of events 3 • 1 year
|
|
General disorders
Hyponatremia
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
Hypotension
|
48.0%
12/25 • Number of events 14 • 1 year
|
|
General disorders
Hypoxia
|
24.0%
6/25 • Number of events 6 • 1 year
|
|
Blood and lymphatic system disorders
Increased creatinine
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Indigestion
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Infections and infestations
Infection, other
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
Insomnia
|
32.0%
8/25 • Number of events 8 • 1 year
|
|
General disorders
Intolerance to cold
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Joint swelling
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Joint pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Leg tightness
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Lesions
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Lethargy
|
20.0%
5/25 • Number of events 5 • 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Lip swelling
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
Lung effusion
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Malaise
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Nervous system disorders
Mental status change
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Metabolism disorder, other
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
General disorders
Mucositis
|
52.0%
13/25 • Number of events 13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
80.0%
20/25 • Number of events 21 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck discomfort
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Neck pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Neck swelling
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Nervous system disorders
Neuropathy
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
General disorders
Nocturia
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Cardiac disorders
Non-ST segment elevation myocardial infarction
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Odynophagia
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
Oral discomfort
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
General disorders
Oral pain
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnea
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Vascular disorders
Orthostatic hypotension
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Parasthesia
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
General disorders
Parotid glad pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Pelvic pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericarditis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Vascular disorders
Pericatheter DVT
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Peripheral edema
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Peri-rectal discomfort
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Vascular disorders
Petechia
|
4.0%
1/25 • Number of events 2 • 1 year
|
|
Vascular disorders
Phlebitis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Vascular disorders
Pleural effusion
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
20.0%
5/25 • Number of events 5 • 1 year
|
|
Nervous system disorders
Polyneuromyopathy
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Proteinuria
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.0%
1/25 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infiltrates
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
60.0%
15/25 • Number of events 22 • 1 year
|
|
Eye disorders
Red eyes
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Nervous system disorders
Restless leg
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Rhinorrhea
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Nervous system disorders
Seizures
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Sialadenitis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
SIRS
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin wound
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Somnolence
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Sore on tip of penis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Sore throat
|
28.0%
7/25 • Number of events 7 • 1 year
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Supraventricular tachycardia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Cardiac disorders
Tachycardia
|
56.0%
14/25 • Number of events 17 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
20.0%
5/25 • Number of events 5 • 1 year
|
|
Eye disorders
Tearing of eyes
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Temporal wasting
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Tenderness
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Thrombus
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Thrush
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Tongue pain
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
General disorders
Tracheal pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Transfusion reaction event
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Nervous system disorders
Tremors
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection symptoms
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary incontinence
|
16.0%
4/25 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
16.0%
4/25 • Number of events 4 • 1 year
|
|
Reproductive system and breast disorders
Vaginal discharge
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular trigeminy
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Vivid dreams
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
General disorders
Volume overload
|
16.0%
4/25 • Number of events 4 • 1 year
|
|
General disorders
Vomiting
|
28.0%
7/25 • Number of events 7 • 1 year
|
|
Nervous system disorders
Weakness
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Weight loss
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.0%
2/25 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Wrist pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place