Trial Outcomes & Findings for Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor (NCT NCT01350245)
NCT ID: NCT01350245
Last Updated: 2025-05-16
Results Overview
1-year post-transplant disease free survival (DFS), defined as success if a patient is alive and disease free at 1-year post-transplant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
1 year post-transplant
Results posted on
2025-05-16
Participant Flow
Participant milestones
| Measure |
TJU 2 Step Regimen
All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.
Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).
Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.
Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days
Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)
Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)
Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor
Baseline characteristics by cohort
| Measure |
TJU 2 Step Regimen
n=28 Participants
All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.
Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).
Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.
Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days
Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)
Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)
Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do
|
|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year post-transplant1-year post-transplant disease free survival (DFS), defined as success if a patient is alive and disease free at 1-year post-transplant.
Outcome measures
| Measure |
TJU 2 Step Regimen
n=28 Participants
All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.
Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).
Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.
Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days
Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)
Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)
Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do
|
|---|---|
|
Disease-Free Survival (DFS)
|
78.6 percentage of patients
|
PRIMARY outcome
Timeframe: 15 monthsProbability of overall survival at 15 months post-treatment, defined as success if a patient is alive 1-year post-transplant.
Outcome measures
| Measure |
TJU 2 Step Regimen
n=28 Participants
All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.
Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).
Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.
Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days
Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)
Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)
Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do
|
|---|---|
|
Probability of Overall Survival at 15 Months Post-treatment
|
85 percentage of probability
|
Adverse Events
TJU 2 Step Regimen
Serious events: 19 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TJU 2 Step Regimen
n=28 participants at risk
All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.
Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).
Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.
Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days
Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)
Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)
Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bone marrow cellularity
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Infection
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
10.7%
3/28 • Number of events 3
|
|
General disorders
Fever
|
28.6%
8/28 • Number of events 10
|
|
General disorders
Headache
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
3.6%
1/28 • Number of events 1
|
|
Immune system disorders
CMV reactivation
|
14.3%
4/28 • Number of events 4
|
|
General disorders
BK cystitis
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Nausea
|
3.6%
1/28 • Number of events 1
|
|
Blood and lymphatic system disorders
HHV-6 infection
|
7.1%
2/28 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Subdural hematoma
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Brain injury from subdural hematoma
|
3.6%
1/28 • Number of events 1
|
|
Blood and lymphatic system disorders
Sepsis
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Cholecystitis
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Hypoxia
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Acute infusion reaction
|
3.6%
1/28 • Number of events 1
|
Other adverse events
| Measure |
TJU 2 Step Regimen
n=28 participants at risk
All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.
Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).
Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.
Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days
Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)
Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)
Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do
|
|---|---|
|
General disorders
Headache
|
64.3%
18/28 • Number of events 30
|
|
General disorders
Decreased appetite
|
25.0%
7/28 • Number of events 7
|
|
Psychiatric disorders
Anxiety
|
67.9%
19/28 • Number of events 22
|
|
General disorders
Rigors
|
25.0%
7/28 • Number of events 8
|
|
Cardiac disorders
Tachycardia
|
71.4%
20/28 • Number of events 35
|
|
General disorders
Malaise
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Oral discomfort
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Sore throat
|
10.7%
3/28 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
82.1%
23/28 • Number of events 52
|
|
Skin and subcutaneous tissue disorders
Ulcer
|
3.6%
1/28 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Rectal pain
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Fatigue
|
92.9%
26/28 • Number of events 27
|
|
General disorders
Back pain
|
46.4%
13/28 • Number of events 16
|
|
General disorders
Insomnia
|
64.3%
18/28 • Number of events 21
|
|
General disorders
Dry mouth
|
39.3%
11/28 • Number of events 12
|
|
Psychiatric disorders
Hallucinations
|
7.1%
2/28 • Number of events 2
|
|
Nervous system disorders
Parasthesia of foot
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Dysphagia
|
10.7%
3/28 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Tongue sores
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.7%
10/28 • Number of events 10
|
|
Gastrointestinal disorders
Epigastric pain/heartburn
|
32.1%
9/28 • Number of events 11
|
|
General disorders
Odynophagia
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Alopecia
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Clubbing of extremities
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Gum pain at site of tooth extraction
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Itching
|
35.7%
10/28 • Number of events 12
|
|
Blood and lymphatic system disorders
Hypertension
|
42.9%
12/28 • Number of events 16
|
|
General disorders
Cheek pain
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Jaw pain
|
10.7%
3/28 • Number of events 3
|
|
General disorders
Nausea
|
39.3%
11/28 • Number of events 13
|
|
General disorders
Leg pain
|
21.4%
6/28 • Number of events 6
|
|
General disorders
Swollen eyelid
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Hand pain
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Abdominal pain
|
60.7%
17/28 • Number of events 25
|
|
Nervous system disorders
Numbness/tingling
|
17.9%
5/28 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
89.3%
25/28 • Number of events 58
|
|
Gastrointestinal disorders
Constipation
|
46.4%
13/28 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
39.3%
11/28 • Number of events 14
|
|
General disorders
Cold-like symptoms
|
7.1%
2/28 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Flushing/erythema
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis
|
85.7%
24/28 • Number of events 24
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
25.0%
7/28 • Number of events 9
|
|
Eye disorders
Vision - flashing lights
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Vomiting
|
7.1%
2/28 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
35.7%
10/28 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
7.1%
2/28 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Mild desquamation on fingers
|
3.6%
1/28 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Knee - decreased range of motion
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
10.7%
3/28 • Number of events 3
|
|
General disorders
Plaque on tongue
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Fever
|
85.7%
24/28 • Number of events 58
|
|
Blood and lymphatic system disorders
Hypotension
|
67.9%
19/28 • Number of events 28
|
|
General disorders
Vasovagal syncope
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Dizziness/lightheaded
|
42.9%
12/28 • Number of events 16
|
|
Renal and urinary disorders
Dysuria
|
35.7%
10/28 • Number of events 13
|
|
General disorders
Tremors
|
21.4%
6/28 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
53.6%
15/28 • Number of events 23
|
|
General disorders
General pain
|
10.7%
3/28 • Number of events 3
|
|
General disorders
Pain at PICC site
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Anorexia
|
28.6%
8/28 • Number of events 8
|
|
General disorders
Sweats
|
10.7%
3/28 • Number of events 3
|
|
Eye disorders
Blurry vision
|
14.3%
4/28 • Number of events 4
|
|
General disorders
Night sweats
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Chills
|
28.6%
8/28 • Number of events 11
|
|
General disorders
Abdominal cramps
|
10.7%
3/28 • Number of events 3
|
|
General disorders
Cytomegalovirus reactivation
|
17.9%
5/28 • Number of events 5
|
|
General disorders
Hip pain
|
14.3%
4/28 • Number of events 4
|
|
Psychiatric disorders
Decreased sense of well-being
|
3.6%
1/28 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypokalemia
|
10.7%
3/28 • Number of events 4
|
|
General disorders
Muscle pain
|
28.6%
8/28 • Number of events 8
|
|
General disorders
Puffy face
|
3.6%
1/28 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
7/28 • Number of events 7
|
|
General disorders
Hyponatremia
|
17.9%
5/28 • Number of events 6
|
|
General disorders
Leg cramping
|
3.6%
1/28 • Number of events 1
|
|
Renal and urinary disorders
Perinephric fluid
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Head cold
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Clostridium difficile
|
21.4%
6/28 • Number of events 8
|
|
Psychiatric disorders
Depression
|
25.0%
7/28 • Number of events 7
|
|
Renal and urinary disorders
Nocturia
|
32.1%
9/28 • Number of events 9
|
|
General disorders
Muscle weakness
|
3.6%
1/28 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing problems
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
7.1%
2/28 • Number of events 2
|
|
Nervous system disorders
Neuropathy
|
25.0%
7/28 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Edema
|
14.3%
4/28 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Diminished breath sounds
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Knee pain
|
10.7%
3/28 • Number of events 3
|
|
Renal and urinary disorders
Decreased urine output
|
25.0%
7/28 • Number of events 8
|
|
Renal and urinary disorders
BK viremia
|
3.6%
1/28 • Number of events 1
|
|
Eye disorders
Visual acuity change/weakness
|
10.7%
3/28 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Papules
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.7%
3/28 • Number of events 3
|
|
General disorders
Groin pain
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Heel/ankle pain
|
7.1%
2/28 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
2/28 • Number of events 2
|
|
Cardiac disorders
Ventricular systolic dysfunction
|
10.7%
3/28 • Number of events 3
|
|
Renal and urinary disorders
Hematuria
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Trouble sleeping
|
25.0%
7/28 • Number of events 9
|
|
General disorders
Lethargic
|
39.3%
11/28 • Number of events 11
|
|
General disorders
Hypoxia
|
21.4%
6/28 • Number of events 9
|
|
Eye disorders
Dry eyes
|
10.7%
3/28 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Mouth ulceration
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Nose dryness
|
3.6%
1/28 • Number of events 1
|
|
Blood and lymphatic system disorders
Fluid overload
|
25.0%
7/28 • Number of events 8
|
|
Blood and lymphatic system disorders
Increased creatinine
|
25.0%
7/28 • Number of events 10
|
|
General disorders
Hiccups
|
10.7%
3/28 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Burning of soles of hands and feet
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Ear pain
|
14.3%
4/28 • Number of events 4
|
|
General disorders
Shoulder pain
|
14.3%
4/28 • Number of events 4
|
|
General disorders
Eye pain
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
14.3%
4/28 • Number of events 6
|
|
General disorders
Bloated feeling
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Arm swelling
|
14.3%
4/28 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
2/28 • Number of events 2
|
|
Eye disorders
Retinal hemorrhage
|
7.1%
2/28 • Number of events 2
|
|
Hepatobiliary disorders
Increased LFTs
|
14.3%
4/28 • Number of events 6
|
|
General disorders
Neck pain
|
7.1%
2/28 • Number of events 3
|
|
Psychiatric disorders
Mild distress
|
3.6%
1/28 • Number of events 1
|
|
Blood and lymphatic system disorders
Pericather thrombus
|
10.7%
3/28 • Number of events 3
|
|
Psychiatric disorders
Frustration
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Meningitis
|
3.6%
1/28 • Number of events 1
|
|
Eye disorders
Photophobia
|
10.7%
3/28 • Number of events 3
|
|
Renal and urinary disorders
Urinary incontinence
|
10.7%
3/28 • Number of events 3
|
|
Renal and urinary disorders
Orange urine
|
3.6%
1/28 • Number of events 1
|
|
Nervous system disorders
Seizures
|
3.6%
1/28 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
21.4%
6/28 • Number of events 6
|
|
Blood and lymphatic system disorders
Hypernatremia
|
3.6%
1/28 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Abdominal distension
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Penile lesion
|
3.6%
1/28 • Number of events 2
|
|
Cardiac disorders
Bradycardia
|
7.1%
2/28 • Number of events 3
|
|
Renal and urinary disorders
Polyuria
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.6%
1/28 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
7.1%
2/28 • Number of events 3
|
|
Blood and lymphatic system disorders
Internal jugular thrombus
|
3.6%
1/28 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Opisthotonus
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Blisters
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Enlarged lymph node
|
3.6%
1/28 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Gastroparesis pain
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Chest pain
|
28.6%
8/28 • Number of events 10
|
|
Gastrointestinal disorders
Indigestion
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Neck stiffness
|
10.7%
3/28 • Number of events 6
|
|
Blood and lymphatic system disorders
Orthostatic hypotension
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Neutropenic colitis
|
3.6%
1/28 • Number of events 1
|
|
Ear and labyrinth disorders
Ringing in ears
|
3.6%
1/28 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
7.1%
2/28 • Number of events 2
|
|
Psychiatric disorders
Altered mental status
|
7.1%
2/28 • Number of events 2
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
3.6%
1/28 • Number of events 1
|
|
Blood and lymphatic system disorders
HHV-6 reactivation
|
7.1%
2/28 • Number of events 2
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
3.6%
1/28 • Number of events 1
|
|
Psychiatric disorders
Speech or memory change
|
3.6%
1/28 • Number of events 1
|
|
Nervous system disorders
Sensitivity to hot/cold
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Swollen face
|
3.6%
1/28 • Number of events 1
|
|
Blood and lymphatic system disorders
Electrolyte imbalance
|
32.1%
9/28 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infiltrates
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Pain at lung biopsy site
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Difficulty walking
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Feet pain
|
10.7%
3/28 • Number of events 3
|
|
General disorders
Malnutrition
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Weight loss
|
3.6%
1/28 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelet infusion reaction
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Hot flashes
|
3.6%
1/28 • Number of events 1
|
|
Psychiatric disorders
Auditory hallucinations
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
10.7%
3/28 • Number of events 3
|
|
Blood and lymphatic system disorders
Elevated ferritin
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Arm pain
|
10.7%
3/28 • Number of events 5
|
|
Eye disorders
Tearing of eyes
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Swollen ankles
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Thrush
|
7.1%
2/28 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Dehydration
|
7.1%
2/28 • Number of events 2
|
|
Cardiac disorders
Volume overload
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hives
|
7.1%
2/28 • Number of events 2
|
|
Blood and lymphatic system disorders
Hypercholesterolemia
|
3.6%
1/28 • Number of events 1
|
|
Reproductive system and breast disorders
Vagina - whitish coating
|
3.6%
1/28 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperlipidemia
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Bone pain
|
7.1%
2/28 • Number of events 3
|
|
Psychiatric disorders
Discouraged
|
3.6%
1/28 • Number of events 1
|
|
Eye disorders
Blindness
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Penile/scrotum pain
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Penile blister
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Tongue lumps
|
3.6%
1/28 • Number of events 1
|
|
Psychiatric disorders
Nightmares
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Altered taste
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Parotitis
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Difficulty concentrating
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Visual disturbance
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Shin pain
|
3.6%
1/28 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint aches
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Low TSH
|
3.6%
1/28 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place