Trial Outcomes & Findings for Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer (NCT NCT00975975)
NCT ID: NCT00975975
Last Updated: 2016-02-26
Results Overview
The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Transplant (Day 0) up to 1 year
Results posted on
2016-02-26
Participant Flow
This protocol has 17 patients. The study was stopped prior to 20 due to the meeting of a stopping rule of 5 or more deaths within the first 15 patients. An additional patient was enrolled after the stopping rule was met. This patient was followed for safety/AE but is not included in the analysis of the efficacy measures, as recommended by the IRB.
Participant milestones
| Measure |
Overall
Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Overall
Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
|
|---|---|
|
Overall Study
Death
|
6
|
Baseline Characteristics
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
Baseline characteristics by cohort
| Measure |
Overall
n=17 Participants
Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
|
|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 7.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 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
|
PRIMARY outcome
Timeframe: Transplant (Day 0) up to 1 yearPopulation: All patients enrolled and received treatment
The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD
Outcome measures
| Measure |
Overall
n=17 Participants
Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
|
|---|---|
|
Grade 3-4 Acute GVHD Rate
|
29.4 percentage of participants
Interval 10.3 to 56.0
|
SECONDARY outcome
Timeframe: Transplant (Day 0) up to 1 yearPopulation: All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
Outcome measures
| Measure |
Overall
n=16 Participants
Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
|
|---|---|
|
Time to Neutrophil Engraftment
|
13.5 days
Interval 10.0 to 14.0
|
SECONDARY outcome
Timeframe: Transplant (Day 0) up to 1 yearPopulation: All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.
Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
Outcome measures
| Measure |
Overall
n=16 Participants
Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
|
|---|---|
|
Time to Platelet Engraftment
|
12.0 days
Interval 8.0 to 18.0
|
Adverse Events
Overall
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall
n=17 participants at risk
Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
|
|---|---|
|
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Cardiac disorders
CONDUCTION ABNORMALITY/ATRIOVENTRICULAR HEART BLOCK - ASYSTOLE
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
DIARRHEA
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
PAIN - ABDOMEN NOS
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION - OTHER
|
23.5%
4/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - BLOOD
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Injury, poisoning and procedural complications
THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Investigations
CREATININE
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Investigations
PLATELETS
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Nervous system disorders
PAIN - HEAD/HEADACHE
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
Other adverse events
| Measure |
Overall
n=17 participants at risk
Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
|
|---|---|
|
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Blood and lymphatic system disorders
LYMPHATICS - OTHER
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Blood and lymphatic system disorders
PALPITATIONS
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Blood and lymphatic system disorders
PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL FIBRILLATION
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA
|
29.4%
5/17 • From transplant until the end of the study, for up to 2 years
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA - PVCS
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Ear and labyrinth disorders
AUDITORY/EAR - OTHER
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Eye disorders
DRY EYE SYNDROME
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Eye disorders
OCULAR/VISUAL - OTHER
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Eye disorders
VISION-BLURRED VISION
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Eye disorders
VITREOUS HEMORRHAGE
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
23.5%
4/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
DIARRHEA
|
82.4%
14/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
FLATULENCE
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION)
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
NAUSEA
|
64.7%
11/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
PAIN - ABDOMEN NOS
|
35.3%
6/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
PAIN - DENTAL/TEETH/PERIDONTAL
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
ULCER, GI - ESOPHAGUS
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Gastrointestinal disorders
VOMITING
|
58.8%
10/17 • From transplant until the end of the study, for up to 2 years
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
General disorders
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
|
47.1%
8/17 • From transplant until the end of the study, for up to 2 years
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
82.4%
14/17 • From transplant until the end of the study, for up to 2 years
|
|
General disorders
HOT FLASHES/FLUSHES
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
General disorders
HYPOTHERMIA
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
General disorders
PAIN - OTHER
|
47.1%
8/17 • From transplant until the end of the study, for up to 2 years
|
|
General disorders
RIGORS/CHILLS
|
23.5%
4/17 • From transplant until the end of the study, for up to 2 years
|
|
General disorders
SWEATING (DIAPHORESIS)
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Hepatobiliary disorders
ASCITES (NON-MALIGNANT)
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Hepatobiliary disorders
BILIRUBIN (HYPERBILIRUBINEMIA)
|
82.4%
14/17 • From transplant until the end of the study, for up to 2 years
|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION - OTHER
|
82.4%
14/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - BLOOD
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - COLON
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - ORAL CAVITY-GUMS (GINGIVITIS)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - SINUS
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - SKIN (CELLULITIS)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS
|
35.3%
6/17 • From transplant until the end of the study, for up to 2 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS
|
29.4%
5/17 • From transplant until the end of the study, for up to 2 years
|
|
Injury, poisoning and procedural complications
THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Investigations
ALKALINE PHOSPHATASE
|
70.6%
12/17 • From transplant until the end of the study, for up to 2 years
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
82.4%
14/17 • From transplant until the end of the study, for up to 2 years
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
82.4%
14/17 • From transplant until the end of the study, for up to 2 years
|
|
Investigations
CREATININE
|
82.4%
14/17 • From transplant until the end of the study, for up to 2 years
|
|
Investigations
IRON OVERLOAD
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Investigations
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY
|
29.4%
5/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
41.2%
7/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
ANOREXIA
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
23.5%
4/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
EDEMA: HEAD AND NECK
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
EDEMA: LIMB
|
82.4%
14/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
EDEMA: TRUNK/GENITAL
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
52.9%
9/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
35.3%
6/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
23.5%
4/17 • From transplant until the end of the study, for up to 2 years
|
|
Metabolism and nutrition disorders
SODIUM, SERUM-LOW (HYPONATREMIA)
|
23.5%
4/17 • From transplant until the end of the study, for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
JOINT-FUNCTION
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - BACK
|
23.5%
4/17 • From transplant until the end of the study, for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - BONE
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - EXTREMITY-LIMB
|
35.3%
6/17 • From transplant until the end of the study, for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - JOINT
|
23.5%
4/17 • From transplant until the end of the study, for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - MUSCLE
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - NECK
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Nervous system disorders
CONFUSION
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Nervous system disorders
CONSTIPATION
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Nervous system disorders
DIZZINESS
|
23.5%
4/17 • From transplant until the end of the study, for up to 2 years
|
|
Nervous system disorders
ENCEPHALOPATHY
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Nervous system disorders
INSOMNIA
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Nervous system disorders
NEUROLOGY - OTHER
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Nervous system disorders
PAIN - HEAD/HEADACHE
|
41.2%
7/17 • From transplant until the end of the study, for up to 2 years
|
|
Nervous system disorders
SEIZURE
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Nervous system disorders
TREMOR
|
41.2%
7/17 • From transplant until the end of the study, for up to 2 years
|
|
Psychiatric disorders
MOOD ALTERATION - ANXIETY
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Psychiatric disorders
MOOD ALTERATION - DEPRESSION
|
23.5%
4/17 • From transplant until the end of the study, for up to 2 years
|
|
Psychiatric disorders
PSYCHOSIS (HALLUCINATIONS/DELUSIONS)
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Renal and urinary disorders
BLADDER SPASMS
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Renal and urinary disorders
PAIN - BLADDER
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Renal and urinary disorders
RENAL FAILURE
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Renal and urinary disorders
URINE COLOR CHANGE
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Reproductive system and breast disorders
SEXUAL/REPRODUCTIVE FUNCTION - OTHER
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
APNEA
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM, WHEEZING
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
52.9%
9/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
70.6%
12/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
HICCOUGHS (HICCUPS, SINGULTUS)
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
52.9%
9/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
PAIN - CHEST WALL
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
PAIN - CHEST/THORAX NOS
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
PAIN - THROAT/PHARYNX/LARYNX
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
29.4%
5/17 • From transplant until the end of the study, for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
29.4%
5/17 • From transplant until the end of the study, for up to 2 years
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
64.7%
11/17 • From transplant until the end of the study, for up to 2 years
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Skin and subcutaneous tissue disorders
SKIN BREAKDOWN/DECUBITUS ULCER
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Vascular disorders
HEMORRHAGE, GI - LOWER GI NOS
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Vascular disorders
HEMORRHAGE, GI - VARICES (RECTAL)
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Vascular disorders
HEMORRHAGE, GU - BLADDER
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
|
Vascular disorders
HEMORRHAGE, GU - URINARY NOS
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Vascular disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE
|
11.8%
2/17 • From transplant until the end of the study, for up to 2 years
|
|
Vascular disorders
HEMORRHAGE/BLEEDING - OTHER
|
17.6%
3/17 • From transplant until the end of the study, for up to 2 years
|
|
Vascular disorders
HYPERTENSION
|
29.4%
5/17 • From transplant until the end of the study, for up to 2 years
|
|
Vascular disorders
HYPOTENSION
|
29.4%
5/17 • From transplant until the end of the study, for up to 2 years
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
5.9%
1/17 • From transplant until the end of the study, for up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place