Trial Outcomes & Findings for Sparing Conversion to Abnormal TCD (Transcranial Doppler) Elevation (SCATE) (NCT NCT01531387)
NCT ID: NCT01531387
Last Updated: 2016-02-08
Results Overview
The primary endpoint of the SCATE trial is the cumulative incidence of conversion to abnormal maximum TAMV (time-averaged mean velocity) measured by transcranial doppler (TCD) ultrasonography. Subjects must have conditional velocities at baseline, defined as 170 - 199 cm/sec, which indicate moderate stroke risk. Abnormal velocities are defined as ≥ 200 cm/sec, which indicate high stroke risk. The number of conversions from conditional velocities to abnormal velocities in each treatment arm will be compared as the primary outcome.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
38 participants
Primary outcome timeframe
30 months
Results posted on
2016-02-08
Participant Flow
22 participants were randomized (e.g., a total of 38 participants enrolled, but only 22 participants were randomized to treatment)
Participant milestones
| Measure |
Hydroxyurea
Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs.
|
Standard Therapy: Observation
Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
| Measure |
Hydroxyurea
Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs.
|
Standard Therapy: Observation
Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
|
|---|---|---|
|
Overall Study
Early termination of study
|
11
|
11
|
Baseline Characteristics
Sparing Conversion to Abnormal TCD (Transcranial Doppler) Elevation (SCATE)
Baseline characteristics by cohort
| Measure |
Standard Therapy: Observation
n=11 Participants
Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
|
Hydroxyurea
n=11 Participants
Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
6.3 Years
STANDARD_DEVIATION 1.5 • n=99 Participants
|
6 Years
STANDARD_DEVIATION 2.4 • n=107 Participants
|
6.15 Years
STANDARD_DEVIATION 1.95 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
Jamaica
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 monthsPopulation: No participants reached 30 months of treatment prior to study termination; therefore, the primary outcome measure was not analyzed.
The primary endpoint of the SCATE trial is the cumulative incidence of conversion to abnormal maximum TAMV (time-averaged mean velocity) measured by transcranial doppler (TCD) ultrasonography. Subjects must have conditional velocities at baseline, defined as 170 - 199 cm/sec, which indicate moderate stroke risk. Abnormal velocities are defined as ≥ 200 cm/sec, which indicate high stroke risk. The number of conversions from conditional velocities to abnormal velocities in each treatment arm will be compared as the primary outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.
This secondary outcome measure will be the highest TAMV obtained in specific arteries. Serial TCD velocities are measured throughout the SCATE trial and will be compared to the baseline value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.
The cumulative incidence of neurological events as a secondary endpoint, which include both stroke and non-stroke neurological events, will be determined over the treatment period for both standard and alternative arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.
The cumulative incidence of non-neurological sickle cell-related events, including vaso-occlusion and splenic sequestration, will be estimated over the treatment period for both standard and alternative arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.
Standard Quality of Life measure will be taken during specific time points, as well as one newly-developed Sickle Cell Disease Quality of Life measure.
Outcome measures
Outcome data not reported
Adverse Events
Hydroxyurea
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Standard Therapy: Observation
Serious events: 11 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hydroxyurea
n=11 participants at risk
Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs.
|
Standard Therapy: Observation
n=11 participants at risk
Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
27.3%
3/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
General disorders
Fever
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Hepatobiliary disorders
Hepatobiliary Disorder
|
18.2%
2/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Infections and infestations
Infections and Infestations
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Infections and infestations
Lung Infection
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
General disorders
Acute Chest Syndrome
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
General disorders
Acute Splenic Sequestration
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
General disorders
Vaso-occlusive Event
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
General disorders
AST
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
Other adverse events
| Measure |
Hydroxyurea
n=11 participants at risk
Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs.
|
Standard Therapy: Observation
n=11 participants at risk
Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
General disorders
Fever
|
18.2%
2/11 • Number of events 2 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
18.2%
2/11 • Number of events 2 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
General disorders
Flu Like Symptoms
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
General disorders
Non Cardiac Chest Pain
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
General disorders
Pain
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Hepatobiliary disorders
Hepatobiliary Disorders
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Infections and infestations
Infections and Infestations
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Infections and infestations
Lung infections
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Infections and infestations
Lymph Glad Infection
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Infections and infestations
Tooth Infection
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Infections and infestations
Upper Respiratory Infection
|
18.2%
2/11 • Number of events 2 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
9.1%
1/11 • Number of events 3 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 3 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
18.2%
2/11 • Number of events 2 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Respiratory, thoracic and mediastinal disorders
Dysnea
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Blood and lymphatic system disorders
Acute Chest Syndrome
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Blood and lymphatic system disorders
Acute Stlenic sequestration
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Blood and lymphatic system disorders
Vaso-occlusive Event
|
18.2%
2/11 • Number of events 2 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
27.3%
3/11 • Number of events 4 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Blood and lymphatic system disorders
ANC
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Blood and lymphatic system disorders
ARC
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Blood and lymphatic system disorders
AST
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Blood and lymphatic system disorders
Hemoglobin
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
18.2%
2/11 • Number of events 3 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Blood and lymphatic system disorders
Bilirubin
|
18.2%
2/11 • Number of events 2 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue dissorder other
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
|
Vascular disorders
hypertension
|
0.00%
0/11 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
9.1%
1/11 • Number of events 1 • May 2012 - Jan 2014 = 20 months
AEs below grade 2 were not recorded for the SCATE trial
|
Additional Information
James M. Boyett, PhD
St. Jude Children's Research Hospital
Phone: 901-595-4986
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place