Trial Outcomes & Findings for Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies (NCT NCT00593554)
NCT ID: NCT00593554
Last Updated: 2018-04-10
Results Overview
To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
thru 6 months after transplant
Results posted on
2018-04-10
Participant Flow
This protocol had 9 enrolled patients, but one patient never received a transplant nor was randomized. There had been no efficacy or safety data entered for this patient, and they are excluded from the results.
Participant milestones
| Measure |
Treatment Without Paliferim
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
|
Treatment With Palifermin
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Treatment Without Paliferim
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
|
Treatment With Palifermin
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Disease Progression
|
1
|
2
|
Baseline Characteristics
Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies
Baseline characteristics by cohort
| Measure |
Treatment Without Paliferim
n=3 Participants
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
|
Treatment With Palifermin
n=5 Participants
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 13.73 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 12.21 • n=7 Participants
|
44.6 years
STANDARD_DEVIATION 11.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: thru 6 months after transplantPopulation: Patients who received a transplant
To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented.
Outcome measures
| Measure |
Treatment Without Paliferim
n=3 Participants
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
|
Treatment With Palifermin
n=5 Participants
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
|---|---|---|
|
Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation
|
33 percentage of patients
Interval 0.0 to 91.0
|
0 percentage of patients
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Patients who received a transplant
The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.
Outcome measures
| Measure |
Treatment Without Paliferim
n=3 Participants
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
|
Treatment With Palifermin
n=5 Participants
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
|---|---|---|
|
Regimen-related Toxicity
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Transplant (Day 0) up to 1 yearPopulation: Patients who received a transplant
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) \> 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided.
Outcome measures
| Measure |
Treatment Without Paliferim
n=3 Participants
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
|
Treatment With Palifermin
n=5 Participants
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
|---|---|---|
|
Time to Neutrophil Engraftment
|
15 days
Interval 11.0 to 23.0
|
14 days
Interval 7.0 to 28.0
|
SECONDARY outcome
Timeframe: Transplant (Day 0) up to 1 yearPopulation: Patients who received a transplant and who achieved platelet recovery/engraftment of platelets
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. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.
Outcome measures
| Measure |
Treatment Without Paliferim
n=3 Participants
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
|
Treatment With Palifermin
n=5 Participants
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
|---|---|---|
|
Time to Platelet Engraftment
|
22.5 days
Interval 17.0 to 28.0
|
20 days
Interval 14.0 to 73.0
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Patients who received a transplant
Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.
Outcome measures
| Measure |
Treatment Without Paliferim
n=3 Participants
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
|
Treatment With Palifermin
n=5 Participants
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
|---|---|---|
|
Acute Graft vs. Host Disease (GvHD)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Patients who received a transplant
Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study.
Outcome measures
| Measure |
Treatment Without Paliferim
n=3 Participants
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
|
Treatment With Palifermin
n=5 Participants
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
|---|---|---|
|
Chronic Graft vs. Host Disease (GvHD)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 through 1 year post transplantationPopulation: Patients who received a transplant
Number of unique patients with bacterial and/or viral infections reported.
Outcome measures
| Measure |
Treatment Without Paliferim
n=3 Participants
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
|
Treatment With Palifermin
n=5 Participants
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
|---|---|---|
|
Frequency of Infection
|
2 Participants
|
5 Participants
|
Adverse Events
Treatment Without Paliferim
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment With Palifermin
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Without Paliferim
n=3 participants at risk
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
|
Treatment With Palifermin
n=5 participants at risk
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
|---|---|---|
|
General disorders
PAIN - OTHER
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION - OTHER
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
Other adverse events
| Measure |
Treatment Without Paliferim
n=3 participants at risk
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
|
Treatment With Palifermin
n=5 participants at risk
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation: 8 Gy on Day -9
Thiotepa: 5 mg/kg/d on Day -8 to -7
Fludarabine: 40 mg/m2/d on Day -6 to -3
Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2
Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
|---|---|---|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER
|
33.3%
1/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Reproductive system and breast disorders
HEMORRHAGE, GU - VAGINA
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Reproductive system and breast disorders
IRREGULAR MENSES (CHANGE FROM BASELINE)
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Reproductive system and breast disorders
PAIN - PERINEUM
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
33.3%
1/3 • Up to 1 year
|
60.0%
3/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
100.0%
3/3 • Up to 1 year
|
80.0%
4/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE
|
33.3%
1/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - RESPIRATORY TRACT NOS
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
66.7%
2/3 • Up to 1 year
|
60.0%
3/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - PHARYNX
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CAVITY/PARANASAL SINUS REACTIONS
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PAIN - THROAT/PHARYNX/LARYNX
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
66.7%
2/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - CATHETER-RELATED
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - COLON
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - LIP/PERIORAL
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - ORAL CAVITY-GUMS (GINGIVITIS)
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - SINUS
|
0.00%
0/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS
|
0.00%
0/3 • Up to 1 year
|
60.0%
3/5 • Up to 1 year
|
|
Injury, poisoning and procedural complications
RASH: DERMATITIS ASSOCIATED WITH RADIATION - RADIATION
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Investigations
ALKALINE PHOSPHATASE
|
100.0%
3/3 • Up to 1 year
|
80.0%
4/5 • Up to 1 year
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
100.0%
3/3 • Up to 1 year
|
100.0%
5/5 • Up to 1 year
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
100.0%
3/3 • Up to 1 year
|
80.0%
4/5 • Up to 1 year
|
|
Investigations
CREATININE
|
66.7%
2/3 • Up to 1 year
|
80.0%
4/5 • Up to 1 year
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/3 • Up to 1 year
|
80.0%
4/5 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
PAIN - BACK
|
66.7%
2/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
PAIN - BONE
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
PAIN - EXTREMITY-LIMB
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
PAIN - JOINT
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
PAIN - MUSCLE
|
0.00%
0/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Nervous system disorders
DIZZINESS
|
33.3%
1/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Nervous system disorders
ENCEPHALOPATHY
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Nervous system disorders
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
33.3%
1/3 • Up to 1 year
|
60.0%
3/5 • Up to 1 year
|
|
Nervous system disorders
PAIN - HEAD/HEADACHE
|
66.7%
2/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Psychiatric disorders
CONFUSION
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Psychiatric disorders
MENTAL STATUS
|
0.00%
0/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Psychiatric disorders
MOOD ALTERATION - DEPRESSION
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Renal and urinary disorders
HEMORRHAGE, GU - BLADDER
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Renal and urinary disorders
HEMORRHAGE, GU - URINARY NOS
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Renal and urinary disorders
RENAL FAILURE
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Blood and lymphatic system disorders
COAGULATION - OTHER
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
|
33.3%
1/3 • Up to 1 year
|
80.0%
4/5 • Up to 1 year
|
|
Blood and lymphatic system disorders
LYMPHATICS - OTHER
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Blood and lymphatic system disorders
THROMBOTIC MICROANGIOPATHY (E.G., THROMBOTIC THROMBOCYTOPENIC PURPURA [TTP] OR HEMOLYTIC UREMIC SYND
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Cardiac disorders
LEFT VENTRICULAR DIASTOLIC DYSFUNCTION
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Cardiac disorders
PERICARDIAL EFFUSION (NON-MALIGNANT)
|
33.3%
1/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL FIBRILLATION
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA
|
100.0%
3/3 • Up to 1 year
|
80.0%
4/5 • Up to 1 year
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA - VENTRICULAR TACHYCARDIA
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Eye disorders
OCULAR/VISUAL - OTHER
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Eye disorders
VISION-BLURRED VISION
|
33.3%
1/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Gastrointestinal disorders
ASCITES (NON-MALIGNANT)
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Gastrointestinal disorders
CONSTIPATION
|
33.3%
1/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Gastrointestinal disorders
DIARRHEA
|
100.0%
3/3 • Up to 1 year
|
100.0%
5/5 • Up to 1 year
|
|
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
66.7%
2/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Gastrointestinal disorders
ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION)
|
0.00%
0/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY
|
33.3%
1/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - LARGE BOWEL
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY
|
66.7%
2/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Gastrointestinal disorders
NAUSEA
|
100.0%
3/3 • Up to 1 year
|
100.0%
5/5 • Up to 1 year
|
|
Gastrointestinal disorders
PAIN - ABDOMEN NOS
|
66.7%
2/3 • Up to 1 year
|
60.0%
3/5 • Up to 1 year
|
|
Gastrointestinal disorders
PAIN - ORAL CAVITY
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Gastrointestinal disorders
PAIN - RECTUM
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Gastrointestinal disorders
VOMITING
|
100.0%
3/3 • Up to 1 year
|
100.0%
5/5 • Up to 1 year
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
General disorders
EDEMA: LIMB
|
100.0%
3/3 • Up to 1 year
|
100.0%
5/5 • Up to 1 year
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
100.0%
3/3 • Up to 1 year
|
100.0%
5/5 • Up to 1 year
|
|
General disorders
PAIN - OTHER
|
33.3%
1/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
General disorders
PAIN - PAIN NOS
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
General disorders
RIGORS/CHILLS
|
0.00%
0/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Hepatobiliary disorders
BILIRUBIN (HYPERBILIRUBINEMIA)
|
100.0%
3/3 • Up to 1 year
|
80.0%
4/5 • Up to 1 year
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Hepatobiliary disorders
HEPATOBILIARY/PANCREAS - OTHER
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Infections and infestations
COLITIS, INFECTIOUS (E.G., CLOSTRIDIUM DIFFICILE)
|
33.3%
1/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Infections and infestations
INFECTION - OTHER
|
100.0%
3/3 • Up to 1 year
|
60.0%
3/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY)
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - ORAL CAVITY-GUMS (GINGIVITIS)
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - VAGINA
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - BLADDER (URINARY)
|
0.00%
0/3 • Up to 1 year
|
60.0%
3/5 • Up to 1 year
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - BLOOD
|
33.3%
1/3 • Up to 1 year
|
60.0%
3/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
0.00%
0/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
0.00%
0/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
66.7%
2/3 • Up to 1 year
|
40.0%
2/5 • Up to 1 year
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Vascular disorders
HYPOTENSION
|
33.3%
1/3 • Up to 1 year
|
20.0%
1/5 • Up to 1 year
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
33.3%
1/3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place