Trial Outcomes & Findings for Hydroxyurea to Prevent Organ Damage in Children With Sickle Cell Anemia (NCT NCT00006400)
NCT ID: NCT00006400
Last Updated: 2020-08-19
Results Overview
Primary Endpoint: Spleen function was assessed by uptake of 99mTc sulfur colloid on liver-spleen scan before initiation of treatment (baseline) and 2 years later (exit). The results of each of the two scans were categorized as normal, functional but abnormal, or not functional by a panel of nuclear medicine specialists blinded to treatment assignment. The proportion of patients whose paired scans demonstrated a decline in splenic function was compared in the hydroxyurea versus placebo groups. The change in splenic function from baseline to 2 years was defined as worse if it changed from normal to decreased or absent, or decreased to absent; and not worse if it changed from decreased to decreased, normal to normal, or decreased to normal.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
193 participants
Primary outcome timeframe
Before initiation of treatment and at 2 years
Results posted on
2020-08-19
Participant Flow
200 patients planned; 233 patients screened; 197 patients eligible for study participation; 193 patients randomized to study treatment; 191 patients initiated study treatment
Participant milestones
| Measure |
Hydroxyurea
Participants will receive hydroxyurea.
|
Placebo
Participants will receive placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
97
|
|
Overall Study
COMPLETED
|
83
|
84
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hydroxyurea to Prevent Organ Damage in Children With Sickle Cell Anemia
Baseline characteristics by cohort
| Measure |
Hydroxyurea
n=96 Participants
Participants will receive hydroxyurea.
|
Placebo
n=97 Participants
Participants will receive placebo.
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
96 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
193 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
|
13.57 Months
STANDARD_DEVIATION 2.60 • n=99 Participants
|
13.56 Months
STANDARD_DEVIATION 2.74 • n=107 Participants
|
13.56 Months
STANDARD_DEVIATION 2.66 • n=206 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
94 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
181 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
96 participants
n=99 Participants
|
97 participants
n=107 Participants
|
193 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Before initiation of treatment and at 2 yearsPopulation: Subjects who had baseline and 2 years splenic function measurements, and had baseline measurement different from absent splenic function. A total of 26 hydroxyurea and 23 placebo subjects had missing data or had absent splenic function at baseline.
Primary Endpoint: Spleen function was assessed by uptake of 99mTc sulfur colloid on liver-spleen scan before initiation of treatment (baseline) and 2 years later (exit). The results of each of the two scans were categorized as normal, functional but abnormal, or not functional by a panel of nuclear medicine specialists blinded to treatment assignment. The proportion of patients whose paired scans demonstrated a decline in splenic function was compared in the hydroxyurea versus placebo groups. The change in splenic function from baseline to 2 years was defined as worse if it changed from normal to decreased or absent, or decreased to absent; and not worse if it changed from decreased to decreased, normal to normal, or decreased to normal.
Outcome measures
| Measure |
Hydroxyurea
n=70 Participants
Participants will receive hydroxyurea.
Hydroxyurea: Participants will receive hydroxyurea.
|
Placebo
n=74 Participants
Participants will receive placebo.
Placebo: Participants will receive placebo.
|
|---|---|---|
|
Treatment Differences of the Change in Qualitative Splenic Function From Baseline
Worse
|
19 Participants
|
28 Participants
|
|
Treatment Differences of the Change in Qualitative Splenic Function From Baseline
Not worse
|
51 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Before initiation of treatment and at 2 yearsPopulation: Subjects who had baseline and 2 years measurements
DTPA GFR was originally a co-primary efficacy outcome for the study. Later in May 29, 2009, this measurement was discontinued because of statistical futility (an extremely small chance that the difference between treatment groups would be statistically significant for this outcome) and the small risk posed by the radiation exposure involved with performing the DTPA GFR test. Subjects who had missing data at baseline or 2 years measurement were excluded from the analysis (29 subjects from the hydroxurea, and 31 subjects from the placebo group excluded).
Outcome measures
| Measure |
Hydroxyurea
n=67 Participants
Participants will receive hydroxyurea.
Hydroxyurea: Participants will receive hydroxyurea.
|
Placebo
n=66 Participants
Participants will receive placebo.
Placebo: Participants will receive placebo.
|
|---|---|---|
|
Change From Baseline in the Renal Function That Was Measured by Diethylenetriaminepentaacetic Acid (DTPA) Glomerular Filtration Rate (GFR)
|
22.56 mL/min/1.73m^2
Standard Deviation 54.67
|
20.74 mL/min/1.73m^2
Standard Deviation 51.07
|
SECONDARY outcome
Timeframe: Before initiation of treatment and at 2 yearsPopulation: All subjects who had baseline and 2 years GFR calculated using Schwartz formula (0.55× height (cm)/serum creatinine (mg/dL)).
Schwartz formula used to calculate GFR is: 0.55× height (cm)/serum creatinine (mg/dL). Where height is in cm and serum creatinine is in mg/dL. Children with missing baseline or 2 years GFR were excluded from the analysis.
Outcome measures
| Measure |
Hydroxyurea
n=70 Participants
Participants will receive hydroxyurea.
Hydroxyurea: Participants will receive hydroxyurea.
|
Placebo
n=76 Participants
Participants will receive placebo.
Placebo: Participants will receive placebo.
|
|---|---|---|
|
Change From Baseline in the Renal Function That Was Measured by Glomerular Filtration Rate (GFR) (Calculated Using Schwartz Formula)
|
28.65 mL/min/1.73m^2
Standard Deviation 76.46
|
33.36 mL/min/1.73m^2
Standard Deviation 95.85
|
SECONDARY outcome
Timeframe: Before initiation of treatment and at 2 yearsPopulation: All subjects who had baseline and 2 years GFR calculated using the new Schwartz formula (39.1× \[height (cm)/serum creatinine (mg/dL)\]0.516 × \[1.8/cystatin C\]0.294 × \[30/blood urea nitrogen\]0.169 × \[1.099\]if male × \[height(m)/1.4\]0.188).
GFR was calculated using new Schwartz formula: 39.1× \[height (cm)/serum creatinine (mg/dL)\]0.516 × \[1.8/cystatin C\]0.294 × \[30/blood urea nitrogen\]0.169 × \[1.099\]if male × \[height(m)/1.4\]0.188. Children with missing baseline or 2 years GFR were excluded from the analysis.
Outcome measures
| Measure |
Hydroxyurea
n=34 Participants
Participants will receive hydroxyurea.
Hydroxyurea: Participants will receive hydroxyurea.
|
Placebo
n=47 Participants
Participants will receive placebo.
Placebo: Participants will receive placebo.
|
|---|---|---|
|
Change From Baseline in the Renal Function That Was Measured by GFR (Calculated Using New Schwartz Formula)
|
10.57 mL/min/1.73m^2
Standard Deviation 20.78
|
14.33 mL/min/1.73m^2
Standard Deviation 24.01
|
Adverse Events
Hydroxyurea
Serious events: 19 serious events
Other events: 95 other events
Deaths: 0 deaths
Placebo
Serious events: 35 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hydroxyurea
n=96 participants at risk
Participants were to receive hydroxyurea.
|
Placebo
n=97 participants at risk
Participants were to receive placebo.
|
|---|---|---|
|
Blood and lymphatic system disorders
Splenic Sequestration
|
11.5%
11/96 • Number of events 16 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
12.4%
12/97 • Number of events 17 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Respiratory, thoracic and mediastinal disorders
Acute Chest Syndrome
|
6.2%
6/96 • Number of events 7 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
19.6%
19/97 • Number of events 28 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Blood and lymphatic system disorders
Acute chest syndrome
|
1.0%
1/96 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
0.00%
0/97 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Nervous system disorders
STROKE, WITH NEUROLOGIC DEFICIT
|
0.00%
0/96 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
1.0%
1/97 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
General disorders
Pain
|
1.0%
1/96 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
0.00%
0/97 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
ACUTE OSTEOMYELITIS
|
0.00%
0/96 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
1.0%
1/97 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Blood and lymphatic system disorders
APLASTIC CRISIS
|
0.00%
0/96 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
2.1%
2/97 • Number of events 2 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
General disorders
FEVER > 101.5°F(38.4°C)
|
1.0%
1/96 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
0.00%
0/97 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
SEPSIS OR MENINGITIS
|
0.00%
0/96 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
2.1%
2/97 • Number of events 2 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Blood and lymphatic system disorders
anemia (Hgb 6.3 - given PRBC transfusion)
|
0.00%
0/96 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
1.0%
1/97 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
Bacteremia
|
0.00%
0/96 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
1.0%
1/97 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
Streptococcus pneumonieae
|
0.00%
0/96 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
1.0%
1/97 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Injury, poisoning and procedural complications
Possible Accidental Hydroxyurea overdose
|
1.0%
1/96 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
0.00%
0/97 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Investigations
ABNORMAL TCD
|
1.0%
1/96 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
3.1%
3/97 • Number of events 3 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/96 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
1.0%
1/97 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Nervous system disorders
encephalopathy (indeterminate etiology)
|
0.00%
0/96 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
1.0%
1/97 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Nervous system disorders
severe obstructive sleep apnea
|
0.00%
0/96 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
1.0%
1/97 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Vascular disorders
DVT
|
1.0%
1/96 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
0.00%
0/97 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
Acute chest syndrome
|
1.0%
1/96 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
0.00%
0/97 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
Other adverse events
| Measure |
Hydroxyurea
n=96 participants at risk
Participants were to receive hydroxyurea.
|
Placebo
n=97 participants at risk
Participants were to receive placebo.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
SKIN INFECTION, FUNGAL
|
1.0%
1/96 • Number of events 1 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
6.2%
6/97 • Number of events 7 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
General disorders
FEVER >101.5 F (38.4 C)
|
78.1%
75/96 • Number of events 231 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
84.5%
82/97 • Number of events 272 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
86.5%
83/96 • Number of events 298 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
79.4%
77/97 • Number of events 326 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY INFECTION
|
8.3%
8/96 • Number of events 12 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
14.4%
14/97 • Number of events 16 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
General disorders
Pain
|
52.1%
50/96 • Number of events 131 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
63.9%
62/97 • Number of events 268 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Musculoskeletal and connective tissue disorders
Pain
|
15.6%
15/96 • Number of events 20 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
27.8%
27/97 • Number of events 49 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Gastrointestinal disorders
Pain
|
10.4%
10/96 • Number of events 13 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
15.5%
15/97 • Number of events 35 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
Viral Syndrome
|
47.9%
46/96 • Number of events 69 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
47.4%
46/97 • Number of events 80 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Respiratory, thoracic and mediastinal disorders
Viral Syndrome
|
4.2%
4/96 • Number of events 4 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
5.2%
5/97 • Number of events 6 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
Otitis Media
|
39.6%
38/96 • Number of events 80 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
49.5%
48/97 • Number of events 103 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Ear and labyrinth disorders
Otitis Media
|
11.5%
11/96 • Number of events 12 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
10.3%
10/97 • Number of events 13 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
GASTROENTERITIS
|
34.4%
33/96 • Number of events 45 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
32.0%
31/97 • Number of events 47 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Gastrointestinal disorders
GASTROENTERITIS
|
7.3%
7/96 • Number of events 10 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
3.1%
3/97 • Number of events 3 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Blood and lymphatic system disorders
SPLENOMEGALY
|
33.3%
32/96 • Number of events 105 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
36.1%
35/97 • Number of events 84 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Gastrointestinal disorders
CONSTIPATION
|
16.7%
16/96 • Number of events 23 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
34.0%
33/97 • Number of events 65 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
SKIN INFECTION, FUNGAL
|
15.6%
15/96 • Number of events 21 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
13.4%
13/97 • Number of events 14 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Musculoskeletal and connective tissue disorders
DACTYLITIS
|
14.6%
14/96 • Number of events 23 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
44.3%
43/97 • Number of events 123 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
SKIN INFECTION, BACTERIAL
|
5.2%
5/96 • Number of events 5 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
9.3%
9/97 • Number of events 14 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
Pneumonia
|
11.5%
11/96 • Number of events 14 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
21.6%
21/97 • Number of events 28 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
3/96 • Number of events 3 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
11.3%
11/97 • Number of events 12 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.5%
11/96 • Number of events 15 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
12.4%
12/97 • Number of events 18 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.9%
21/96 • Number of events 25 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
29.9%
29/97 • Number of events 43 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
12/96 • Number of events 15 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
14.4%
14/97 • Number of events 14 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
10.4%
10/96 • Number of events 12 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
15.5%
15/97 • Number of events 21 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
CONJUNCTIVITIS
|
16.7%
16/96 • Number of events 18 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
13.4%
13/97 • Number of events 16 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Gastrointestinal disorders
Emesis
|
7.3%
7/96 • Number of events 9 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
9.3%
9/97 • Number of events 11 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
URI
|
2.1%
2/96 • Number of events 3 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
6.2%
6/97 • Number of events 9 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Injury, poisoning and procedural complications
Insect Bites
|
12.5%
12/96 • Number of events 15 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
15.5%
15/97 • Number of events 22 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
11/96 • Number of events 13 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
14.4%
14/97 • Number of events 15 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
Bronchitis
|
4.2%
4/96 • Number of events 7 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
6.2%
6/97 • Number of events 7 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.3%
8/96 • Number of events 11 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
3.1%
3/97 • Number of events 4 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
Urinary Tract Infection
|
5.2%
5/96 • Number of events 7 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
11.3%
11/97 • Number of events 13 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
General disorders
Low Grade Fever (<101.5)
|
9.4%
9/96 • Number of events 12 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
14.4%
14/97 • Number of events 18 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Respiratory, thoracic and mediastinal disorders
Reactive Airway Disease
|
5.2%
5/96 • Number of events 9 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
9.3%
9/97 • Number of events 13 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHEA
|
5.2%
5/96 • Number of events 5 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
11.3%
11/97 • Number of events 15 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
PHARYNGITIS
|
7.3%
7/96 • Number of events 7 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
5.2%
5/97 • Number of events 6 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Infections and infestations
SINUSITIS
|
3.1%
3/96 • Number of events 3 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
6.2%
6/97 • Number of events 6 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
8.3%
8/96 • Number of events 13 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
6.2%
6/97 • Number of events 9 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
|
Skin and subcutaneous tissue disorders
Diaper DERMATITIS
|
7.3%
7/96 • Number of events 7 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
4.1%
4/97 • Number of events 5 • From randomization through study completion, an average of 1.93 years.
The CC, NHLBI, and the DSMB continuously monitored the safety of study treatments. A serious adverse event(SAE) was defined as an untoward medical event that is fatal, life threatening, causes/prolongs a hospitalization, or poses a risk of permanent disability, i.e. SAE was defined as one or more of the following: 1. Death 2. Life-threatening events 3. Prolonged hospitalization (greater than 7 days) 4. Splenic sequestration crisis 5. Stroke, TIA 6. Acute chest syndrome 7. ICU admissions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place