Trial Outcomes & Findings for Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission (NCT NCT00070135)
NCT ID: NCT00070135
Last Updated: 2018-06-12
Results Overview
Percentage of participants who were alive and relapse free at 2 years for patients who were matched with an unrelated donor for transplant. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method. A relapse is defined as any of the following: * Reappearance of leukemia blasts cells in peripheral blood * \>5% blasts in the marrow, not attributable to another cause (e.g., bone marrow regeneration) * If there are no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow ≥ 1 week later with \>5% blasts is necessary to meet the criteria for relapse * The development of extramedullary leukemia or leukemic cells in the cerebral spinal fluid
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
2 years
Results posted on
2018-06-12
Participant Flow
Between November 2004 and 2011, 121 participants were registered and received transplants at 21 centers.
Seven (7) participants were excluded from the all analyses after they were deemed ineligible.
Participant milestones
| Measure |
Treatment (Fludarabine, Busulfan, Allogeneic PBSC)
PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m\^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m\^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover.
|
|---|---|
|
Overall Study
STARTED
|
114
|
|
Overall Study
COMPLETED
|
114
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
Baseline characteristics by cohort
| Measure |
Treatment (Fludarabine, Busulfan, Allogeneic PBSC)
n=114 Participants
PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m\^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m\^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
|
Transplant Donor Type
Matched unrelated donor
|
59 participants
n=5 Participants
|
|
Transplant Donor Type
Matched related donor
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants who received a matched unrelated donor were included in this analysis.
Percentage of participants who were alive and relapse free at 2 years for patients who were matched with an unrelated donor for transplant. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method. A relapse is defined as any of the following: * Reappearance of leukemia blasts cells in peripheral blood * \>5% blasts in the marrow, not attributable to another cause (e.g., bone marrow regeneration) * If there are no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow ≥ 1 week later with \>5% blasts is necessary to meet the criteria for relapse * The development of extramedullary leukemia or leukemic cells in the cerebral spinal fluid
Outcome measures
| Measure |
Treatment (Fludarabine, Busulfan, Allogeneic PBSC)
n=59 Participants
PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m\^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m\^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover.
|
|---|---|
|
2 Year Disease Free Survival In Unrelated Donor Recipient Group
|
40 percentage of participants
Interval 29.0 to 55.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPercentage of participants who were alive and relapse free at 2 years for all patients. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Treatment (Fludarabine, Busulfan, Allogeneic PBSC)
n=114 Participants
PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m\^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m\^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover.
|
|---|---|
|
2 Year DFS for All Patients
|
42 percentage of participants
Interval 33.0 to 52.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPercentage of patients who died due to causes other than relapse
Outcome measures
| Measure |
Treatment (Fludarabine, Busulfan, Allogeneic PBSC)
n=114 Participants
PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m\^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m\^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover.
|
|---|---|
|
Non-relapse Mortality (NRM)
|
16 percentage of patients
|
Adverse Events
Treatment (Fludarabine, Busulfan, Allogeneic PBSC)
Serious events: 38 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Fludarabine, Busulfan, Allogeneic PBSC)
n=114 participants at risk
PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m\^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m\^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover
|
|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
0.88%
1/114 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.1%
7/114 • Number of events 8
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
11.4%
13/114 • Number of events 24
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.6%
3/114 • Number of events 5
|
|
Cardiac disorders
Atrial fibrillation
|
0.88%
1/114 • Number of events 1
|
|
Cardiac disorders
Cardiac pain
|
0.88%
1/114 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.88%
1/114 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
1.8%
2/114 • Number of events 2
|
|
Cardiac disorders
Myocardial ischemia
|
1.8%
2/114 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
0.88%
1/114 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
1.8%
2/114 • Number of events 2
|
|
Ear and labyrinth disorders
Ear disorder
|
0.88%
1/114 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.88%
1/114 • Number of events 1
|
|
Endocrine disorders
Adrenal insufficiency
|
0.88%
1/114 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
0.88%
1/114 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
2.6%
3/114 • Number of events 4
|
|
Eye disorders
Vision blurred
|
0.88%
1/114 • Number of events 1
|
|
Eye disorders
Watering eyes
|
1.8%
2/114 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal distension
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
5/114 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
6.1%
7/114 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhea
|
14.0%
16/114 • Number of events 25
|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
3/114 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
3/114 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
1.8%
2/114 • Number of events 2
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.6%
3/114 • Number of events 4
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.8%
2/114 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
2.6%
3/114 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
7.0%
8/114 • Number of events 15
|
|
Gastrointestinal disorders
Oral pain
|
0.88%
1/114 • Number of events 3
|
|
Gastrointestinal disorders
Tooth disorder
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
3/114 • Number of events 4
|
|
General disorders
Chest pain
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Chills
|
4.4%
5/114 • Number of events 5
|
|
General disorders
Death NOS
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Disease progression
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Edema limbs
|
8.8%
10/114 • Number of events 12
|
|
General disorders
Fatigue
|
13.2%
15/114 • Number of events 23
|
|
General disorders
Fever
|
6.1%
7/114 • Number of events 7
|
|
General disorders
General symptom
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Ill-defined disorder
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Localized edema
|
1.8%
2/114 • Number of events 2
|
|
General disorders
Multi-organ failure
|
1.8%
2/114 • Number of events 2
|
|
General disorders
Pain
|
1.8%
2/114 • Number of events 2
|
|
Immune system disorders
Hypersensitivity
|
1.8%
2/114 • Number of events 2
|
|
Infections and infestations
Bladder infection
|
2.6%
3/114 • Number of events 4
|
|
Infections and infestations
Bronchitis
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
2.6%
3/114 • Number of events 3
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Encephalitis infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Infection
|
1.8%
2/114 • Number of events 2
|
|
Infections and infestations
Infectious colitis
|
1.8%
2/114 • Number of events 2
|
|
Infections and infestations
Lip infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Opportunistic infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Paranasal sinus infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Phlebitis infective
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.8%
2/114 • Number of events 2
|
|
Infections and infestations
Sepsis
|
6.1%
7/114 • Number of events 9
|
|
Infections and infestations
Sinusitis
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Soft tissue infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
3.5%
4/114 • Number of events 6
|
|
Infections and infestations
Wound infection
|
0.88%
1/114 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.88%
1/114 • Number of events 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.88%
1/114 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
10.5%
12/114 • Number of events 12
|
|
Investigations
Alkaline phosphatase increased
|
9.6%
11/114 • Number of events 17
|
|
Investigations
Aspartate aminotransferase increased
|
8.8%
10/114 • Number of events 12
|
|
Investigations
Blood bilirubin increased
|
6.1%
7/114 • Number of events 8
|
|
Investigations
Creatinine increased
|
11.4%
13/114 • Number of events 16
|
|
Investigations
INR increased
|
1.8%
2/114 • Number of events 3
|
|
Investigations
Laboratory test abnormal
|
3.5%
4/114 • Number of events 8
|
|
Investigations
Leukocyte count decreased
|
4.4%
5/114 • Number of events 8
|
|
Investigations
Lymphocyte count decreased
|
5.3%
6/114 • Number of events 13
|
|
Investigations
Neutrophil count decreased
|
18.4%
21/114 • Number of events 26
|
|
Investigations
Platelet count decreased
|
24.6%
28/114 • Number of events 52
|
|
Investigations
Serum cholesterol increased
|
0.88%
1/114 • Number of events 3
|
|
Investigations
Weight gain
|
6.1%
7/114 • Number of events 13
|
|
Investigations
Weight loss
|
6.1%
7/114 • Number of events 14
|
|
Metabolism and nutrition disorders
Acidosis
|
0.88%
1/114 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
7.0%
8/114 • Number of events 11
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
13.2%
15/114 • Number of events 24
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.88%
1/114 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
2/114 • Number of events 2
|
|
Metabolism and nutrition disorders
Iron overload
|
1.8%
2/114 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
7.9%
9/114 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
6.1%
7/114 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
1.8%
2/114 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.88%
1/114 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
12.3%
14/114 • Number of events 21
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
1.8%
2/114 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
4.4%
5/114 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
7.9%
9/114 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
5.3%
6/114 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
4.4%
5/114 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
2.6%
3/114 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.88%
1/114 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.4%
5/114 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
7/114 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.5%
4/114 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.5%
4/114 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.88%
1/114 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.4%
5/114 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.88%
1/114 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.88%
1/114 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.88%
1/114 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.5%
4/114 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.88%
1/114 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplasia
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
2.6%
3/114 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
5.3%
6/114 • Number of events 7
|
|
Nervous system disorders
Dysgeusia
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Facial nerve disorder
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Headache
|
5.3%
6/114 • Number of events 6
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.8%
2/114 • Number of events 2
|
|
Nervous system disorders
Memory impairment
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Neurological disorder NOS
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Speech disorder
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Tremor
|
1.8%
2/114 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
3.5%
4/114 • Number of events 4
|
|
Psychiatric disorders
Anxiety
|
4.4%
5/114 • Number of events 5
|
|
Psychiatric disorders
Confusion
|
3.5%
4/114 • Number of events 4
|
|
Psychiatric disorders
Depression
|
5.3%
6/114 • Number of events 9
|
|
Psychiatric disorders
Insomnia
|
4.4%
5/114 • Number of events 5
|
|
Psychiatric disorders
Psychosis
|
0.88%
1/114 • Number of events 1
|
|
Renal and urinary disorders
Bladder pain
|
0.88%
1/114 • Number of events 1
|
|
Renal and urinary disorders
Bladder spasm
|
0.88%
1/114 • Number of events 2
|
|
Renal and urinary disorders
Cystitis
|
0.88%
1/114 • Number of events 1
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.88%
1/114 • Number of events 1
|
|
Renal and urinary disorders
Kidney pain
|
0.88%
1/114 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.8%
2/114 • Number of events 2
|
|
Renal and urinary disorders
Urethral pain
|
0.88%
1/114 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
2.6%
3/114 • Number of events 4
|
|
Renal and urinary disorders
Urinary incontinence
|
1.8%
2/114 • Number of events 3
|
|
Renal and urinary disorders
Urinary retention
|
2.6%
3/114 • Number of events 3
|
|
Reproductive system and breast disorders
Pelvic floor muscle weakness
|
0.88%
1/114 • Number of events 1
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.88%
1/114 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.8%
2/114 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
6/114 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.3%
14/114 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.6%
11/114 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.8%
2/114 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.1%
7/114 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
4.4%
5/114 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.6%
3/114 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.88%
1/114 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.88%
1/114 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.8%
2/114 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.88%
1/114 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.88%
1/114 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
5/114 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.88%
1/114 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
17.5%
20/114 • Number of events 31
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.5%
4/114 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.88%
1/114 • Number of events 1
|
|
Vascular disorders
Hematoma
|
0.88%
1/114 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
0.88%
1/114 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
0.88%
1/114 • Number of events 1
|
|
Vascular disorders
Hypertension
|
8.8%
10/114 • Number of events 13
|
|
Vascular disorders
Hypotension
|
9.6%
11/114 • Number of events 15
|
|
Vascular disorders
Thrombosis
|
1.8%
2/114 • Number of events 2
|
Other adverse events
| Measure |
Treatment (Fludarabine, Busulfan, Allogeneic PBSC)
n=114 participants at risk
PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m\^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m\^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover
|
|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
0.88%
1/114 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
39.5%
45/114 • Number of events 49
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
48.2%
55/114 • Number of events 141
|
|
Blood and lymphatic system disorders
Hemolysis
|
3.5%
4/114 • Number of events 6
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.88%
1/114 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.88%
1/114 • Number of events 3
|
|
Cardiac disorders
Cardiac disorder
|
1.8%
2/114 • Number of events 2
|
|
Cardiac disorders
Conduction disorder
|
0.88%
1/114 • Number of events 1
|
|
Cardiac disorders
Left ventricular dysfunction
|
2.6%
3/114 • Number of events 4
|
|
Cardiac disorders
Left ventricular failure
|
4.4%
5/114 • Number of events 6
|
|
Cardiac disorders
Myocardial ischemia
|
0.88%
1/114 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.88%
1/114 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
0.88%
1/114 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
3.5%
4/114 • Number of events 4
|
|
Ear and labyrinth disorders
Ear disorder
|
1.8%
2/114 • Number of events 5
|
|
Ear and labyrinth disorders
Ear pain
|
0.88%
1/114 • Number of events 1
|
|
Ear and labyrinth disorders
External ear pain
|
2.6%
3/114 • Number of events 4
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.6%
3/114 • Number of events 4
|
|
Ear and labyrinth disorders
Tinnitus
|
0.88%
1/114 • Number of events 1
|
|
Endocrine disorders
Adrenal insufficiency
|
0.88%
1/114 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
6.1%
7/114 • Number of events 11
|
|
Eye disorders
Cataract
|
4.4%
5/114 • Number of events 6
|
|
Eye disorders
Conjunctivitis
|
0.88%
1/114 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.88%
1/114 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
13.2%
15/114 • Number of events 38
|
|
Eye disorders
Extraocular muscle paresis
|
0.88%
1/114 • Number of events 1
|
|
Eye disorders
Eye disorder
|
5.3%
6/114 • Number of events 6
|
|
Eye disorders
Eye pain
|
1.8%
2/114 • Number of events 2
|
|
Eye disorders
Optic nerve disorder
|
0.88%
1/114 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.88%
1/114 • Number of events 1
|
|
Eye disorders
Vision blurred
|
3.5%
4/114 • Number of events 4
|
|
Eye disorders
Vitreous hemorrhage
|
0.88%
1/114 • Number of events 1
|
|
Eye disorders
Watering eyes
|
3.5%
4/114 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal distension
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
8.8%
10/114 • Number of events 14
|
|
Gastrointestinal disorders
Anal pain
|
1.8%
2/114 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
1.8%
2/114 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
22.8%
26/114 • Number of events 35
|
|
Gastrointestinal disorders
Diarrhea
|
45.6%
52/114 • Number of events 80
|
|
Gastrointestinal disorders
Dry mouth
|
15.8%
18/114 • Number of events 35
|
|
Gastrointestinal disorders
Dyspepsia
|
15.8%
18/114 • Number of events 29
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
3/114 • Number of events 3
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
14.0%
16/114 • Number of events 18
|
|
Gastrointestinal disorders
Enteritis
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.88%
1/114 • Number of events 3
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
3.5%
4/114 • Number of events 5
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.5%
4/114 • Number of events 8
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Lip pain
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.8%
2/114 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
8.8%
10/114 • Number of events 10
|
|
Gastrointestinal disorders
Nausea
|
43.0%
49/114 • Number of events 76
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Rectal pain
|
1.8%
2/114 • Number of events 3
|
|
Gastrointestinal disorders
Typhlitis
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
21.9%
25/114 • Number of events 30
|
|
General disorders
Chest pain
|
3.5%
4/114 • Number of events 4
|
|
General disorders
Chills
|
17.5%
20/114 • Number of events 23
|
|
General disorders
Edema limbs
|
20.2%
23/114 • Number of events 35
|
|
General disorders
Fatigue
|
52.6%
60/114 • Number of events 128
|
|
General disorders
Fever
|
23.7%
27/114 • Number of events 31
|
|
General disorders
Gait abnormal
|
0.88%
1/114 • Number of events 1
|
|
General disorders
General symptom
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Hypothermia
|
1.8%
2/114 • Number of events 2
|
|
General disorders
Ill-defined disorder
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Injection site reaction
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Localized edema
|
1.8%
2/114 • Number of events 2
|
|
General disorders
Pain
|
13.2%
15/114 • Number of events 18
|
|
Immune system disorders
Hypersensitivity
|
7.9%
9/114 • Number of events 9
|
|
Infections and infestations
Abdominal infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
1.8%
2/114 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
3.5%
4/114 • Number of events 5
|
|
Infections and infestations
Catheter related infection
|
0.88%
1/114 • Number of events 2
|
|
Infections and infestations
Conjunctivitis infective
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Eye infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Gastric infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
2.6%
3/114 • Number of events 4
|
|
Infections and infestations
Ileal infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Infection
|
9.6%
11/114 • Number of events 13
|
|
Infections and infestations
Infectious colitis
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Infectious meningitis
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Lip infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Nail infection
|
0.88%
1/114 • Number of events 2
|
|
Infections and infestations
Opportunistic infection
|
1.8%
2/114 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
6.1%
7/114 • Number of events 7
|
|
Infections and infestations
Scrotal infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Sepsis
|
9.6%
11/114 • Number of events 14
|
|
Infections and infestations
Sinusitis
|
4.4%
5/114 • Number of events 6
|
|
Infections and infestations
Skin infection
|
5.3%
6/114 • Number of events 7
|
|
Infections and infestations
Soft tissue infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
7.9%
9/114 • Number of events 11
|
|
Infections and infestations
Urinary tract infection
|
5.3%
6/114 • Number of events 7
|
|
Infections and infestations
Vaginal infection
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Viral hepatitis
|
1.8%
2/114 • Number of events 2
|
|
Infections and infestations
Wound infection
|
0.88%
1/114 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
1.8%
2/114 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fracture
|
0.88%
1/114 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.8%
2/114 • Number of events 2
|
|
Injury, poisoning and procedural complications
Venous injury - Extremity-lower
|
0.88%
1/114 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.1%
7/114 • Number of events 14
|
|
Investigations
Alanine aminotransferase increased
|
36.0%
41/114 • Number of events 87
|
|
Investigations
Alkaline phosphatase increased
|
29.8%
34/114 • Number of events 70
|
|
Investigations
Amylase increased
|
0.88%
1/114 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
39.5%
45/114 • Number of events 106
|
|
Investigations
Blood bilirubin increased
|
20.2%
23/114 • Number of events 34
|
|
Investigations
CD4 lymphocytes decreased
|
0.88%
1/114 • Number of events 1
|
|
Investigations
Creatinine increased
|
43.9%
50/114 • Number of events 116
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.88%
1/114 • Number of events 2
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.88%
1/114 • Number of events 1
|
|
Investigations
INR increased
|
8.8%
10/114 • Number of events 13
|
|
Investigations
Laboratory test abnormal
|
6.1%
7/114 • Number of events 12
|
|
Investigations
Leukocyte count decreased
|
24.6%
28/114 • Number of events 54
|
|
Investigations
Lymphocyte count decreased
|
22.8%
26/114 • Number of events 44
|
|
Investigations
Neutrophil count decreased
|
83.3%
95/114 • Number of events 157
|
|
Investigations
Platelet count decreased
|
85.1%
97/114 • Number of events 206
|
|
Investigations
Serum cholesterol increased
|
8.8%
10/114 • Number of events 17
|
|
Investigations
Weight gain
|
11.4%
13/114 • Number of events 17
|
|
Investigations
Weight loss
|
10.5%
12/114 • Number of events 16
|
|
Metabolism and nutrition disorders
Anorexia
|
32.5%
37/114 • Number of events 53
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
52.6%
60/114 • Number of events 133
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
1.8%
2/114 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
7.0%
8/114 • Number of events 8
|
|
Metabolism and nutrition disorders
Iron overload
|
1.8%
2/114 • Number of events 2
|
|
Metabolism and nutrition disorders
Obesity
|
0.88%
1/114 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
25.4%
29/114 • Number of events 52
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
22.8%
26/114 • Number of events 48
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
5.3%
6/114 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.88%
1/114 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
43.9%
50/114 • Number of events 87
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
2.6%
3/114 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
11.4%
13/114 • Number of events 15
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
26.3%
30/114 • Number of events 42
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
19.3%
22/114 • Number of events 32
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
35.1%
40/114 • Number of events 76
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
5.3%
6/114 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
8.8%
10/114 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Abdominal soft tissue necrosis
|
0.88%
1/114 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
19/114 • Number of events 34
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.5%
20/114 • Number of events 26
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.3%
14/114 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.6%
3/114 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
0.88%
1/114 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.88%
1/114 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
11.4%
13/114 • Number of events 23
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.4%
5/114 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.88%
1/114 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
3.5%
4/114 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
6/114 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.5%
4/114 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.88%
1/114 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.4%
13/114 • Number of events 24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
1.8%
2/114 • Number of events 2
|
|
Nervous system disorders
Ataxia
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
14.9%
17/114 • Number of events 22
|
|
Nervous system disorders
Dysgeusia
|
7.9%
9/114 • Number of events 18
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Headache
|
24.6%
28/114 • Number of events 37
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
3.5%
4/114 • Number of events 6
|
|
Nervous system disorders
Neuralgia
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Neurological disorder NOS
|
1.8%
2/114 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.0%
8/114 • Number of events 8
|
|
Nervous system disorders
Seizure
|
1.8%
2/114 • Number of events 3
|
|
Nervous system disorders
Sinus pain
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Syncope
|
3.5%
4/114 • Number of events 6
|
|
Nervous system disorders
Tremor
|
8.8%
10/114 • Number of events 16
|
|
Psychiatric disorders
Agitation
|
1.8%
2/114 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
9.6%
11/114 • Number of events 14
|
|
Psychiatric disorders
Confusion
|
7.9%
9/114 • Number of events 15
|
|
Psychiatric disorders
Depression
|
10.5%
12/114 • Number of events 24
|
|
Psychiatric disorders
Insomnia
|
16.7%
19/114 • Number of events 30
|
|
Psychiatric disorders
Psychosis
|
0.88%
1/114 • Number of events 2
|
|
Renal and urinary disorders
Bladder pain
|
0.88%
1/114 • Number of events 1
|
|
Renal and urinary disorders
Bladder spasm
|
1.8%
2/114 • Number of events 2
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
2.6%
3/114 • Number of events 3
|
|
Renal and urinary disorders
Proteinuria
|
0.88%
1/114 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.8%
2/114 • Number of events 2
|
|
Renal and urinary disorders
Urethral stenosis
|
0.88%
1/114 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
8.8%
10/114 • Number of events 18
|
|
Renal and urinary disorders
Urinary incontinence
|
2.6%
3/114 • Number of events 3
|
|
Renal and urinary disorders
Urinary retention
|
0.88%
1/114 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
2.6%
3/114 • Number of events 4
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.8%
2/114 • Number of events 5
|
|
Reproductive system and breast disorders
Irregular menstruation
|
2.6%
3/114 • Number of events 4
|
|
Reproductive system and breast disorders
Perineal pain
|
0.88%
1/114 • Number of events 1
|
|
Reproductive system and breast disorders
Scrotal pain
|
1.8%
2/114 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.88%
1/114 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.88%
1/114 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.0%
8/114 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
24/114 • Number of events 38
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.4%
29/114 • Number of events 52
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.8%
2/114 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.8%
2/114 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.4%
13/114 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Laryngoscopy abnormal
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
3/114 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
1.8%
2/114 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.6%
3/114 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.8%
2/114 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.8%
10/114 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.88%
1/114 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
3.5%
4/114 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.88%
1/114 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.3%
14/114 • Number of events 31
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.88%
1/114 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.2%
15/114 • Number of events 27
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
1.8%
2/114 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
2.6%
3/114 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.5%
4/114 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.88%
1/114 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.3%
22/114 • Number of events 36
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.8%
2/114 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
65.8%
75/114 • Number of events 151
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
7.0%
8/114 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.6%
3/114 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.88%
1/114 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.6%
3/114 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Sweating
|
1.8%
2/114 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.88%
1/114 • Number of events 1
|
|
Vascular disorders
Hematoma
|
1.8%
2/114 • Number of events 3
|
|
Vascular disorders
Hemorrhage
|
1.8%
2/114 • Number of events 2
|
|
Vascular disorders
Hot flashes
|
0.88%
1/114 • Number of events 3
|
|
Vascular disorders
Hypertension
|
34.2%
39/114 • Number of events 68
|
|
Vascular disorders
Hypotension
|
22.8%
26/114 • Number of events 34
|
|
Vascular disorders
Thrombosis
|
3.5%
4/114 • Number of events 4
|
|
Vascular disorders
Vascular disorder
|
0.88%
1/114 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60