Trial Outcomes & Findings for Total Body Irradiation/Fludarabine Based Ablative Haploidentical Transplant for Hematologic Diseases (NCT NCT01336712)
NCT ID: NCT01336712
Last Updated: 2016-01-14
Results Overview
1.1 To estimate the incidence of BK virus-associated hemorrhagic cystitis following a TBI-based myeloablative haploidentical HSCT in patients with high risk hematologic malignancies.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
6 months
Results posted on
2016-01-14
Participant Flow
Participant milestones
| Measure |
Myeloablative Haploidentical Transplant
Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m\^2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
Patient follow up x6 months
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Myeloablative Haploidentical Transplant
Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m\^2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
Patient follow up x6 months
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Total Body Irradiation/Fludarabine Based Ablative Haploidentical Transplant for Hematologic Diseases
Baseline characteristics by cohort
| Measure |
Myeloablative Haploidentical Transplant
n=30 Participants
Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African America
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months1.1 To estimate the incidence of BK virus-associated hemorrhagic cystitis following a TBI-based myeloablative haploidentical HSCT in patients with high risk hematologic malignancies.
Outcome measures
| Measure |
Myeloablative Haploidentical Transplant
n=30 Participants
Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
|
|---|---|
|
Percentage of Patients Experiencing Hemorrhagic Cystitis Post Transplant
|
30 percentage of patients
|
SECONDARY outcome
Timeframe: 2 yearTo obtain estimate of overall survival (OS)
Outcome measures
| Measure |
Myeloablative Haploidentical Transplant
n=30 Participants
Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
|
|---|---|
|
Survival
|
78 percentage of patients analyzed
|
SECONDARY outcome
Timeframe: Day 30Characterize donor hematopoietic chimerism in peripheral blood at day 30 after HSCT.
Outcome measures
| Measure |
Myeloablative Haploidentical Transplant
n=30 Participants
Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
|
|---|---|
|
Percentage of Participatns With Donor Chimerism Post-transplant
|
100 percentage of patients
|
SECONDARY outcome
Timeframe: 2 yearOutcome measures
| Measure |
Myeloablative Haploidentical Transplant
n=30 Participants
Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
|
|---|---|
|
Disease Free Survival (DFS) Percentage
|
73 percentage of patients analyzed
|
SECONDARY outcome
Timeframe: 2 yearOutcome measures
| Measure |
Myeloablative Haploidentical Transplant
n=30 Participants
Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
|
|---|---|
|
Non-relapsed Mortality (NRM) Percentage
|
3 percentage of patients
|
SECONDARY outcome
Timeframe: 2 yearOutcome measures
| Measure |
Myeloablative Haploidentical Transplant
n=30 Participants
Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
|
|---|---|
|
Relapse Rate
|
24 percentage of patients analyzed
|
SECONDARY outcome
Timeframe: 2 yearOutcome measures
| Measure |
Myeloablative Haploidentical Transplant
n=30 Participants
Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
|
|---|---|
|
Cumulative Incidence of Chronic Graft-versus-host Disease
|
56 percentage of patients analyzed
|
Adverse Events
Myeloablative Haploidentical Transplant
Serious events: 13 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Myeloablative Haploidentical Transplant
n=30 participants at risk
Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
|
|---|---|
|
Hepatobiliary disorders
Veno-Occlusive Disease
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
BK Virus
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
anorexia
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
10.0%
3/30 • Number of events 3
|
|
Blood and lymphatic system disorders
Hemolytic Uremic Syndrom
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Nausea & vomiting
|
3.3%
1/30 • Number of events 1
|
|
Renal and urinary disorders
Renal Insufficiency
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar Hemorrhage
|
3.3%
1/30 • Number of events 1
|
|
Cardiac disorders
Syncope
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Sepsis syndrome
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Myeloablative Haploidentical Transplant
n=30 participants at risk
Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
|
|---|---|
|
Gastrointestinal disorders
abcessed tooth
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
abdominal bloating
|
20.0%
6/30 • Number of events 6
|
|
Gastrointestinal disorders
abdominal cramping/discomfort
|
66.7%
20/30 • Number of events 20
|
|
Gastrointestinal disorders
abdominal fullness
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
abdominal muscle soreness (secondary to cough)
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
abdominal tenderness
|
26.7%
8/30 • Number of events 8
|
|
Nervous system disorders
abnormal gait
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
acidosis
|
13.3%
4/30 • Number of events 4
|
|
Immune system disorders
acute GVHD - gut
|
33.3%
10/30 • Number of events 10
|
|
Immune system disorders
acute GVHD - skin
|
26.7%
8/30 • Number of events 8
|
|
Psychiatric disorders
agitation
|
6.7%
2/30 • Number of events 2
|
|
Hepatobiliary disorders
increased alkaline phosphatase
|
66.7%
20/30 • Number of events 20
|
|
Hepatobiliary disorders
increased ALT
|
73.3%
22/30 • Number of events 22
|
|
Blood and lymphatic system disorders
neutropenia
|
86.7%
26/30 • Number of events 26
|
|
Gastrointestinal disorders
anorexia
|
50.0%
15/30 • Number of events 15
|
|
Psychiatric disorders
anxiety
|
86.7%
26/30 • Number of events 26
|
|
Hepatobiliary disorders
increased AST
|
96.7%
29/30 • Number of events 29
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
6.7%
2/30 • Number of events 2
|
|
Renal and urinary disorders
BK Virus
|
33.3%
10/30 • Number of events 10
|
|
Renal and urinary disorders
bladder mass
|
6.7%
2/30 • Number of events 2
|
|
Renal and urinary disorders
bladder pressure
|
6.7%
2/30 • Number of events 2
|
|
Renal and urinary disorders
bladder spasms
|
10.0%
3/30 • Number of events 3
|
|
Blood and lymphatic system disorders
bleeding gums
|
16.7%
5/30 • Number of events 5
|
|
Renal and urinary disorders
blood clots in urine
|
6.7%
2/30 • Number of events 2
|
|
Blood and lymphatic system disorders
blood in sputum
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
blurred vision
|
23.3%
7/30 • Number of events 7
|
|
Renal and urinary disorders
benign prostatic hyperplasia
|
10.0%
3/30 • Number of events 3
|
|
Cardiac disorders
bradycardia
|
20.0%
6/30 • Number of events 6
|
|
Blood and lymphatic system disorders
bruising
|
20.0%
6/30 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
bumps on skin
|
6.7%
2/30 • Number of events 2
|
|
Infections and infestations
c.difficile colitis
|
16.7%
5/30 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
chest discomfort with inspiration
|
6.7%
2/30 • Number of events 2
|
|
Cardiac disorders
chest tightness
|
6.7%
2/30 • Number of events 2
|
|
Investigations
chills
|
73.3%
22/30 • Number of events 22
|
|
Blood and lymphatic system disorders
CMV reactivation
|
50.0%
15/30 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
coarse breath sounds
|
20.0%
6/30 • Number of events 6
|
|
Gastrointestinal disorders
coated tongue
|
16.7%
5/30 • Number of events 5
|
|
Nervous system disorders
confusion
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
constipation
|
63.3%
19/30 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
dry cough
|
16.7%
5/30 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
productive cough
|
13.3%
4/30 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
cough NOS
|
70.0%
21/30 • Number of events 21
|
|
Renal and urinary disorders
increased creatinine
|
53.3%
16/30 • Number of events 16
|
|
Investigations
CVC site bleeding
|
6.7%
2/30 • Number of events 2
|
|
Investigations
CVC site edema
|
6.7%
2/30 • Number of events 2
|
|
Investigations
CVC site soreness
|
10.0%
3/30 • Number of events 3
|
|
Investigations
CVC site tenderness
|
23.3%
7/30 • Number of events 7
|
|
Investigations
deconditioned
|
66.7%
20/30 • Number of events 20
|
|
Gastrointestinal disorders
decreased appetite
|
73.3%
22/30 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
decreased breath sounds
|
50.0%
15/30 • Number of events 15
|
|
Gastrointestinal disorders
decreased fluid intake
|
23.3%
7/30 • Number of events 7
|
|
Gastrointestinal disorders
decreased oral intake
|
16.7%
5/30 • Number of events 5
|
|
Investigations
dehydration
|
16.7%
5/30 • Number of events 5
|
|
Psychiatric disorders
depression
|
63.3%
19/30 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
diaphoresis
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
diarrhea
|
100.0%
30/30 • Number of events 30
|
|
Gastrointestinal disorders
difficulty swallowing
|
33.3%
10/30 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
labored breathing
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
abdominal distention
|
26.7%
8/30 • Number of events 8
|
|
Nervous system disorders
dizziness
|
53.3%
16/30 • Number of events 16
|
|
Nervous system disorders
drowsiness
|
60.0%
18/30 • Number of events 18
|
|
Gastrointestinal disorders
dry heaves
|
16.7%
5/30 • Number of events 5
|
|
Gastrointestinal disorders
dry lips
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
dry mouth
|
60.0%
18/30 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
dry skin
|
63.3%
19/30 • Number of events 19
|
|
Gastrointestinal disorders
dry throat
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
dysgeusia
|
16.7%
5/30 • Number of events 5
|
|
Gastrointestinal disorders
dyspepsia
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
dysphagia
|
20.0%
6/30 • Number of events 6
|
|
Renal and urinary disorders
dysuria
|
60.0%
18/30 • Number of events 18
|
|
Ear and labyrinth disorders
ear fullness
|
6.7%
2/30 • Number of events 2
|
|
Cardiac disorders
edema of hands and feet
|
6.7%
2/30 • Number of events 2
|
|
Cardiac disorders
lower extremity edema
|
60.0%
18/30 • Number of events 18
|
|
Metabolism and nutrition disorders
electrolyte wasting syndrome
|
20.0%
6/30 • Number of events 6
|
|
Blood and lymphatic system disorders
epistaxis
|
36.7%
11/30 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
generalized erythema
|
23.3%
7/30 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
throat erythema
|
10.0%
3/30 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
erythematous palms
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
esophagitis
|
30.0%
9/30 • Number of events 9
|
|
Gastrointestinal disorders
esophageal pain
|
10.0%
3/30 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
exertional shortness of breath
|
16.7%
5/30 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
facial flushing
|
13.3%
4/30 • Number of events 4
|
|
Investigations
fatigue
|
96.7%
29/30 • Number of events 29
|
|
Investigations
fever
|
80.0%
24/30 • Number of events 24
|
|
Musculoskeletal and connective tissue disorders
left lower flank pain
|
6.7%
2/30 • Number of events 2
|
|
Psychiatric disorders
flat affect
|
36.7%
11/30 • Number of events 11
|
|
Gastrointestinal disorders
flatulence
|
10.0%
3/30 • Number of events 3
|
|
Cardiac disorders
fluid overload
|
36.7%
11/30 • Number of events 11
|
|
Infections and infestations
folliculitis
|
13.3%
4/30 • Number of events 4
|
|
Gastrointestinal disorders
gastritis
|
10.0%
3/30 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
generalized body aches
|
36.7%
11/30 • Number of events 11
|
|
Gastrointestinal disorders
GERD
|
80.0%
24/30 • Number of events 24
|
|
Gastrointestinal disorders
gastrointenstinal bleed
|
6.7%
2/30 • Number of events 2
|
|
Psychiatric disorders
hallucinations
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
headache
|
80.0%
24/30 • Number of events 24
|
|
Renal and urinary disorders
hematuria
|
36.7%
11/30 • Number of events 11
|
|
Blood and lymphatic system disorders
hemoptysis
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
hemorrhoids
|
16.7%
5/30 • Number of events 5
|
|
Blood and lymphatic system disorders
anemia
|
93.3%
28/30 • Number of events 28
|
|
Gastrointestinal disorders
hiccups
|
13.3%
4/30 • Number of events 4
|
|
Gastrointestinal disorders
hyperactive bowel sounds
|
10.0%
3/30 • Number of events 3
|
|
Hepatobiliary disorders
hyperbilirubinemia
|
26.7%
8/30 • Number of events 8
|
|
Metabolism and nutrition disorders
hypercalcemia
|
33.3%
10/30 • Number of events 10
|
|
Metabolism and nutrition disorders
hyperglycemia
|
100.0%
30/30 • Number of events 30
|
|
Metabolism and nutrition disorders
hyperkalemia
|
50.0%
15/30 • Number of events 15
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
10.0%
3/30 • Number of events 3
|
|
Metabolism and nutrition disorders
hypernatremia
|
63.3%
19/30 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
hyperpigmented skin
|
43.3%
13/30 • Number of events 13
|
|
Cardiac disorders
hypertension
|
90.0%
27/30 • Number of events 27
|
|
Gastrointestinal disorders
hypoactive bowel sounds
|
16.7%
5/30 • Number of events 5
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
80.0%
24/30 • Number of events 24
|
|
Metabolism and nutrition disorders
hypocalcemia
|
83.3%
25/30 • Number of events 25
|
|
Metabolism and nutrition disorders
hypoglycemia
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
hypokalemia
|
76.7%
23/30 • Number of events 23
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
90.0%
27/30 • Number of events 27
|
|
Metabolism and nutrition disorders
hyponatremia
|
33.3%
10/30 • Number of events 10
|
|
Cardiac disorders
hypotension
|
63.3%
19/30 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
stool incontinence
|
23.3%
7/30 • Number of events 7
|
|
Infections and infestations
bacteremia infection (NOS)
|
20.0%
6/30 • Number of events 6
|
|
Infections and infestations
influenza
|
6.7%
2/30 • Number of events 2
|
|
Psychiatric disorders
insomnia
|
76.7%
23/30 • Number of events 23
|
|
Cardiac disorders
irregular heartbeat
|
13.3%
4/30 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
leg cramping
|
16.7%
5/30 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
leg discomfort (2nd lower extremity edema)
|
6.7%
2/30 • Number of events 2
|
|
Investigations
lethargy
|
36.7%
11/30 • Number of events 11
|
|
Nervous system disorders
lightheadedness
|
10.0%
3/30 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
limited mobility
|
30.0%
9/30 • Number of events 9
|
|
Nervous system disorders
limited sensory perception
|
20.0%
6/30 • Number of events 6
|
|
Nervous system disorders
loss of balance
|
26.7%
8/30 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
lower extremity pain
|
10.0%
3/30 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
lung crackles
|
23.3%
7/30 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
lung infiltrates
|
13.3%
4/30 • Number of events 4
|
|
Blood and lymphatic system disorders
lymphocytopenia
|
40.0%
12/30 • Number of events 12
|
|
Investigations
malaise
|
23.3%
7/30 • Number of events 7
|
|
Gastrointestinal disorders
malnutrition
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
melena
|
6.7%
2/30 • Number of events 2
|
|
Reproductive system and breast disorders
menstrual cramps
|
10.0%
3/30 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
metapneumovirus
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
migraine headaches
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
mouth sores
|
33.3%
10/30 • Number of events 10
|
|
Gastrointestinal disorders
mucositis
|
83.3%
25/30 • Number of events 25
|
|
Musculoskeletal and connective tissue disorders
myalgias
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
30.0%
9/30 • Number of events 9
|
|
Gastrointestinal disorders
nausea
|
96.7%
29/30 • Number of events 29
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
86.7%
26/30 • Number of events 26
|
|
Investigations
night sweats
|
10.0%
3/30 • Number of events 3
|
|
Renal and urinary disorders
nocturia
|
10.0%
3/30 • Number of events 3
|
|
Infections and infestations
oral candida
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
oral lesions
|
6.7%
2/30 • Number of events 2
|
|
Investigations
oral thrush
|
33.3%
10/30 • Number of events 10
|
|
Cardiac disorders
orthostatic hypotension
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
abdominal pain
|
43.3%
13/30 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
ankle pain
|
10.0%
3/30 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
arm pain
|
10.0%
3/30 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
back pain
|
33.3%
10/30 • Number of events 10
|
|
Renal and urinary disorders
bladder pain
|
6.7%
2/30 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
13.3%
4/30 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
20.0%
6/30 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
chest pain (2nd cough)
|
10.0%
3/30 • Number of events 3
|
|
Investigations
CVC site pain
|
10.0%
3/30 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
fingertip pain
|
6.7%
2/30 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
foot pain
|
16.7%
5/30 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
hand pain
|
20.0%
6/30 • Number of events 6
|
|
Gastrointestinal disorders
hemorrhoidal pain
|
6.7%
2/30 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
jaw pain
|
13.3%
4/30 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
26.7%
8/30 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
13.3%
4/30 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
33.3%
10/30 • Number of events 10
|
|
Gastrointestinal disorders
mouth pain
|
43.3%
13/30 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
muscle pain
|
10.0%
3/30 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
13.3%
4/30 • Number of events 4
|
|
Gastrointestinal disorders
throat pain (2nd mucositis)
|
16.7%
5/30 • Number of events 5
|
|
Gastrointestinal disorders
tooth pain
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
pain with swallowing
|
13.3%
4/30 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
pale skin
|
6.7%
2/30 • Number of events 2
|
|
Cardiac disorders
palpitations
|
13.3%
4/30 • Number of events 4
|
|
Nervous system disorders
panic attack
|
6.7%
2/30 • Number of events 2
|
|
Infections and infestations
parainfluenza
|
6.7%
2/30 • Number of events 2
|
|
Investigations
parotid gland edema
|
6.7%
2/30 • Number of events 2
|
|
Investigations
parotid gland tenderness
|
6.7%
2/30 • Number of events 2
|
|
Infections and infestations
parotitis
|
6.7%
2/30 • Number of events 2
|
|
Cardiac disorders
pericardial effusion
|
10.0%
3/30 • Number of events 3
|
|
Nervous system disorders
peripheral neuropathy
|
53.3%
16/30 • Number of events 16
|
|
Gastrointestinal disorders
perirectal irritation
|
16.7%
5/30 • Number of events 5
|
|
Gastrointestinal disorders
perirectal pain
|
10.0%
3/30 • Number of events 3
|
|
Blood and lymphatic system disorders
petechiae
|
16.7%
5/30 • Number of events 5
|
|
Nervous system disorders
photosensitivity
|
6.7%
2/30 • Number of events 2
|
|
Investigations
platelet infusion reaction
|
6.7%
2/30 • Number of events 2
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
96.7%
29/30 • Number of events 29
|
|
Infections and infestations
pneumonia
|
13.3%
4/30 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
postnasal drainage
|
26.7%
8/30 • Number of events 8
|
|
Renal and urinary disorders
prolonged urine stream
|
6.7%
2/30 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
pruritus
|
86.7%
26/30 • Number of events 26
|
|
Respiratory, thoracic and mediastinal disorders
rales
|
13.3%
4/30 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
rash
|
56.7%
17/30 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
rash (arms, thighs)
|
6.7%
2/30 • Number of events 2
|
|
Renal and urinary disorders
renal failure
|
6.7%
2/30 • Number of events 2
|
|
Renal and urinary disorders
acute renal insufficiency
|
43.3%
13/30 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
respiratory insufficiency
|
13.3%
4/30 • Number of events 4
|
|
Nervous system disorders
restless legs
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
40.0%
12/30 • Number of events 12
|
|
Infections and infestations
rhinovirus
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
rhonchi
|
16.7%
5/30 • Number of events 5
|
|
General disorders
rigors
|
20.0%
6/30 • Number of events 6
|
|
Gastrointestinal disorders
saliva thickening
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
scalloped tongue border
|
23.3%
7/30 • Number of events 7
|
|
Reproductive system and breast disorders
scrotal edema
|
6.7%
2/30 • Number of events 2
|
|
General disorders
seasonal allergies
|
20.0%
6/30 • Number of events 6
|
|
Nervous system disorders
sedation
|
10.0%
3/30 • Number of events 3
|
|
Ear and labyrinth disorders
serous otitis
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
30.0%
9/30 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
sinus drainage
|
10.0%
3/30 • Number of events 3
|
|
Nervous system disorders
sinus headache
|
6.7%
2/30 • Number of events 2
|
|
General disorders
sinus pressure
|
6.7%
2/30 • Number of events 2
|
|
General disorders
sinus tenderness
|
10.0%
3/30 • Number of events 3
|
|
General disorders
sinusitis
|
16.7%
5/30 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
skin dyspigmentation
|
6.7%
2/30 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
skin irriation
|
6.7%
2/30 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
skin lesions
|
10.0%
3/30 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
skin tenderness
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
small bowel obstruction
|
6.7%
2/30 • Number of events 2
|
|
General disorders
sneezing
|
13.3%
4/30 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
46.7%
14/30 • Number of events 14
|
|
Nervous system disorders
somnolence
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
sore throat
|
60.0%
18/30 • Number of events 18
|
|
Endocrine disorders
splenomegaly
|
6.7%
2/30 • Number of events 2
|
|
Infections and infestations
staphylococcus hemolyticus bacteremia
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
steroid-induced diabetes
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
stomatitis
|
30.0%
9/30 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
suprapubic tenderness
|
6.7%
2/30 • Number of events 2
|
|
General disorders
facial swelling
|
6.7%
2/30 • Number of events 2
|
|
Cardiac disorders
tachycardia
|
83.3%
25/30 • Number of events 25
|
|
Cardiac disorders
tachypnea
|
10.0%
3/30 • Number of events 3
|
|
Nervous system disorders
taste alteration
|
33.3%
10/30 • Number of events 10
|
|
Gastrointestinal disorders
thick oral secretions
|
6.7%
2/30 • Number of events 2
|
|
General disorders
throat swelling
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
tongue ridging
|
10.0%
3/30 • Number of events 3
|
|
General disorders
tongue swelling
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
tremors
|
30.0%
9/30 • Number of events 9
|
|
Nervous system disorders
tremors (hands)
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
unsteady gait
|
6.7%
2/30 • Number of events 2
|
|
Renal and urinary disorders
urinary frequency
|
76.7%
23/30 • Number of events 23
|
|
Renal and urinary disorders
urinary hesitancy
|
16.7%
5/30 • Number of events 5
|
|
Renal and urinary disorders
urinary incontinence
|
20.0%
6/30 • Number of events 6
|
|
Renal and urinary disorders
urinary retention
|
13.3%
4/30 • Number of events 4
|
|
Renal and urinary disorders
urinary urgency
|
53.3%
16/30 • Number of events 16
|
|
Reproductive system and breast disorders
vaginal bleeding/spotting
|
23.3%
7/30 • Number of events 7
|
|
General disorders
volume depletion
|
20.0%
6/30 • Number of events 6
|
|
General disorders
volume overload
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
vomiting
|
80.0%
24/30 • Number of events 24
|
|
Infections and infestations
vancomycin-resistant enterococci
|
16.7%
5/30 • Number of events 5
|
|
Blood and lymphatic system disorders
leukopenia
|
93.3%
28/30 • Number of events 28
|
|
General disorders
weakness
|
80.0%
24/30 • Number of events 24
|
|
Gastrointestinal disorders
weight gain
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
weight loss
|
73.3%
22/30 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
20.0%
6/30 • Number of events 6
|
Additional Information
Scott R. Solomon, MD (Principal Investigator)
Blood and Marrow Transplant Group of Georgia
Phone: 404-255-1930
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place