Trial Outcomes & Findings for Arginine Therapy for Sickle Cell Disease Pain (NCT NCT02536170)
NCT ID: NCT02536170
Last Updated: 2023-09-06
Results Overview
The total amount of parenteral opioids used by participants measured in mg/kg of IV morphine equivalents. The total is calculated after study drug delivery for participants in the emergency department (ED) and during hospital stay.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
Post study drug delivery to discharge from the hospital (Up to 8 days)
Results posted on
2023-09-06
Participant Flow
Participant milestones
| Measure |
L-Arginine
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
36
|
|
Overall Study
COMPLETED
|
36
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Arginine Therapy for Sickle Cell Disease Pain
Baseline characteristics by cohort
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
34 Participants
n=39 Participants
|
31 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
100 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
13.49 years
STANDARD_DEVIATION 3.76 • n=39 Participants
|
13.63 years
STANDARD_DEVIATION 3.7 • n=41 Participants
|
12.27 years
STANDARD_DEVIATION 4.0 • n=35 Participants
|
13.13 years
STANDARD_DEVIATION 3.84 • n=31 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
56 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
52 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
107 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
108 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=39 Participants
|
36 participants
n=41 Participants
|
36 participants
n=35 Participants
|
108 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Post study drug delivery to discharge from the hospital (Up to 8 days)The total amount of parenteral opioids used by participants measured in mg/kg of IV morphine equivalents. The total is calculated after study drug delivery for participants in the emergency department (ED) and during hospital stay.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Total Parenteral Opioid Use in IV Morphine Equivalents
|
1.77 mg/Kg
Standard Deviation 1.91
|
1.95 mg/Kg
Standard Deviation 2.09
|
2.36 mg/Kg
Standard Deviation 3.14
|
SECONDARY outcome
Timeframe: Discharge (Up to 8 days)The total number of hours spent in the hospital from study drug delivery to time of discharge.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Length of Hospital Stay
|
71.3 hours
Standard Deviation 50.8
|
76.9 hours
Standard Deviation 49.9
|
84.9 hours
Standard Deviation 90.5
|
SECONDARY outcome
Timeframe: Post study drug delivery (Up to 8 hours)Population: Time to vaso-occlusive pain event (VOE) resolution in emergency department could not be determined as none of the participants had pain resolution in the Emergency department and were hospitalized
The total number of hours between study drug delivery and the last parenteral opioid.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Time to Vaso-occlusive Pain Event (VOE) Resolution in Emergency Department
|
NA hours
Standard Deviation NA
Time to vaso-occlusive pain event (VOE) resolution in emergency department could not be determined as none of the participants had pain resolution in the Emergency department and were hospitalized
|
NA hours
Standard Deviation NA
Time to vaso-occlusive pain event (VOE) resolution in emergency department could not be determined as none of the participants had pain resolution in the Emergency department and were hospitalized
|
NA hours
Standard Deviation NA
Time to vaso-occlusive pain event (VOE) resolution in emergency department could not be determined as none of the participants had pain resolution in the Emergency department and were hospitalized
|
SECONDARY outcome
Timeframe: Post study drug delivery until discharge (up to 8 days)The total number of hours between study drug delivery and time of last parenteral opioid use, pain relief improved to tolerate oral pain medications
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Time to Vaso-occlusive Pain Event (VOE) Resolution in Hospital
|
57.3 hours
Standard Deviation 50.8
|
55.1 hours
Standard Deviation 42.9
|
69.3 hours
Standard Deviation 85.1
|
SECONDARY outcome
Timeframe: Baseline, Time of discharge (Up to 8 days)Pain associated with VOE will be measured on a scale of 0-10, by asking subjects to rate their pain level on a subjective scale from 0 to 10, with the ends representing the extreme limits of "no-pain" (0) and "worst pain" (10).
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Change in Vaso-occlusive Pain (VOE) Scores
Emergency Department (ED) arrival Pain Score
|
8.89 score on a scale
Standard Deviation 1.01
|
8.86 score on a scale
Standard Deviation 1.46
|
8.86 score on a scale
Standard Deviation 1.36
|
|
Change in Vaso-occlusive Pain (VOE) Scores
Time of hospital discharge Pain Score
|
4.5 score on a scale
Standard Deviation 3.46
|
4.75 score on a scale
Standard Deviation 3.35
|
4.56 score on a scale
Standard Deviation 2.97
|
|
Change in Vaso-occlusive Pain (VOE) Scores
Hospital Discharge Minus ED Arrival
|
-4.39 score on a scale
Standard Deviation 3.41
|
-4.11 score on a scale
Standard Deviation 3.54
|
-4.31 score on a scale
Standard Deviation 3.09
|
SECONDARY outcome
Timeframe: Until discharge or Hospital Admission (Up to 24 hours)Total hours from time of ED triage to ED discharge or hospital admission.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Length of Emergency Department (ED) Stay
|
6.29 hours
Standard Deviation 15.84
|
5.67 hours
Standard Deviation 12.33
|
4.08 hours
Standard Deviation 4.26
|
SECONDARY outcome
Timeframe: Post emergency department admission (Up to 24 hours)Population: All patients were admitted to the hospital, none was discharged during Emergency Department stay.
Number of participants discharged from ED without a hospital ward admission.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Rate of Emergency Department (ED) Discharge
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post study drug delivery up to hospital discharge (Up to 8 days)Total opioid dose (ORAL + Parenteral) in mg/kg IV morphine equivalents after study drug delivery up to hospital discharge (up to 8 days)
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Total Opioid Dose (ORAL + Parenteral) in mg/kg IV Morphine Equivalents
|
2.11 mg/Kg
Standard Deviation 2.18
|
2.35 mg/Kg
Standard Deviation 2.19
|
2.82 mg/Kg
Standard Deviation 3.65
|
SECONDARY outcome
Timeframe: Duration of study (Up to 8 days)The total number of study drug doses given throughout the study period.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Total Number of Study Drug Doses
|
298 doses
|
330 doses
|
329 doses
|
SECONDARY outcome
Timeframe: Duration of study (Up to 8 days)Number of participants who develop acute chest syndrome (not diagnosed prior to study drug delivery) throughout the study period.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Rate of Acute Chest Syndrome
|
4 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Duration of study (Up to 8 days)Number of participants requiring a blood transfusion throughout the study period.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Rate of Blood Transfusion
|
3 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At time of Emergency Department AdmissionAverage oxygen saturation level of participants at time of ED arrival
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Oxygen Saturation Level
|
95.5 percentage of oxygenated hemoglobin
Standard Deviation 14.8
|
98 percentage of oxygenated hemoglobin
Standard Deviation 1.96
|
98.1 percentage of oxygenated hemoglobin
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: At time of hospital admission and at time of Hospital discharge (Up to 8 days)The difference in oxygen saturation levels from emergency department arrival to hospital discharge.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Oxygen Saturation Level
Oxygen saturation measures at time of emergency Department arrival
|
95.5 percentage of oxygenated hemoglobin
Standard Deviation 14.8
|
98 percentage of oxygenated hemoglobin
Standard Deviation 1.96
|
98.1 percentage of oxygenated hemoglobin
Standard Deviation 2.14
|
|
Oxygen Saturation Level
Oxygen saturation at Hospital Discharge
|
98 percentage of oxygenated hemoglobin
Standard Deviation 2.75
|
98.6 percentage of oxygenated hemoglobin
Standard Deviation 2.11
|
98.4 percentage of oxygenated hemoglobin
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: Post hospital discharge (within 72 hours)Number of ED visits from patients who have been discharged within the previous 72 hours.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Rate of Return Visits to Emergency Department (ED) Within 72 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post hospital discharge (within 72 hours)Number of patients readmitted to the hospital within 72 hours of discharge.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Rate of Hospital Re-admissions Within 72 Hours
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Post hospital discharge (within 30 days)Number of ED visits from patients who have been discharged within the previous 30 days.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Rate of Return Visits to Emergency Department (ED) Within 30 Days
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post hospital discharge (within 30 days)Number of patients readmitted to the hospital within 30 days of discharge.
Outcome measures
| Measure |
L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 Participants
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Rate of Hospital Re-admissions With 30 Days
|
2 Participants
|
7 Participants
|
4 Participants
|
Adverse Events
L-Arginine
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Loading Dose and L-Arginine
Serious events: 9 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
L-Arginine
n=36 participants at risk
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 participants at risk
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 participants at risk
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Cardiac disorders
Re-admission: Acute Chest Syndrome
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
5.6%
2/36 • Number of events 2 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 2 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Vascular disorders
Re-admission: Vaso-Occlusive Pain Event
|
5.6%
2/36 • Number of events 3 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
19.4%
7/36 • Number of events 13 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
8.3%
3/36 • Number of events 4 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Re-admission: Non sickle Cell event
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Cardiac disorders
Prolonged hospitalization: Acute Coronary Syndrome
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Renal and urinary disorders
Prolonged hospitalization: Priapism
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
Other adverse events
| Measure |
L-Arginine
n=36 participants at risk
Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
|
Loading Dose and L-Arginine
n=36 participants at risk
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
|
Placebo
n=36 participants at risk
Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.
Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
|
|---|---|---|---|
|
Cardiac disorders
Acute Chest Syndrome after randomization
|
11.1%
4/36 • Number of events 4 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
8.3%
3/36 • Number of events 3 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Cardiac disorders
Acute Chest Syndrome
|
11.1%
4/36 • Number of events 4 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
11.1%
4/36 • Number of events 4 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
5.6%
2/36 • Number of events 2 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.8%
10/36 • Number of events 10 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
16.7%
6/36 • Number of events 6 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
27.8%
10/36 • Number of events 10 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen administered
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Cardiac disorders
Hypertension
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
2/36 • Number of events 2 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
13.9%
5/36 • Number of events 5 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Nervous system disorders
Headache
|
38.9%
14/36 • Number of events 16 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
27.8%
10/36 • Number of events 10 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
25.0%
9/36 • Number of events 9 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Nervous system disorders
Headache after randomization
|
19.4%
7/36 • Number of events 7 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
11.1%
4/36 • Number of events 4 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
13.9%
5/36 • Number of events 5 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
General disorders
Chills
|
16.7%
6/36 • Number of events 6 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
13.9%
5/36 • Number of events 5 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
13.9%
5/36 • Number of events 5 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
General disorders
Fever
|
19.4%
7/36 • Number of events 7 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
27.8%
10/36 • Number of events 10 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
16.7%
6/36 • Number of events 6 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Gastrointestinal disorders
Anorexia
|
27.8%
10/36 • Number of events 10 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
22.2%
8/36 • Number of events 8 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
16.7%
6/36 • Number of events 6 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
9/36 • Number of events 9 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
25.0%
9/36 • Number of events 9 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
25.0%
9/36 • Number of events 9 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
3/36 • Number of events 3 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
11.1%
4/36 • Number of events 4 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Gastrointestinal disorders
Nausea
|
41.7%
15/36 • Number of events 15 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
47.2%
17/36 • Number of events 17 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
36.1%
13/36 • Number of events 13 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
9/36 • Number of events 9 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
30.6%
11/36 • Number of events 12 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
22.2%
8/36 • Number of events 8 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Gastrointestinal disorders
Vomiting after randomization
|
22.2%
8/36 • Number of events 8 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
13.9%
5/36 • Number of events 5 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
13.9%
5/36 • Number of events 5 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Musculoskeletal and connective tissue disorders
Leg/ Neck/ Hip Pain
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
5.6%
2/36 • Number of events 3 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Vascular disorders
Hematoma
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Splenic Sequestration
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Skin and subcutaneous tissue disorders
Lip Swelling
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Transfusion
|
8.3%
3/36 • Number of events 3 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
5.6%
2/36 • Number of events 2 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
13.9%
5/36 • Number of events 5 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
General disorders
Emergency Department visit after Discharge
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 2 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 2 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Elevated ALT
|
13.9%
5/36 • Number of events 5 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
13.9%
5/36 • Number of events 5 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
11.1%
4/36 • Number of events 4 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Elevated AST
|
16.7%
6/36 • Number of events 6 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
25.0%
9/36 • Number of events 9 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
19.4%
7/36 • Number of events 7 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Elevated Bilirrubin
|
8.3%
3/36 • Number of events 3 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
11.1%
4/36 • Number of events 4 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
5.6%
2/36 • Number of events 2 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Elevated Alkaline Phosphatase
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
5.6%
2/36 • Number of events 2 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Elevated creatinine
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Decreased Neutrophil count
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Anemia/ Decreased Hemoglobin
|
19.4%
7/36 • Number of events 7 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
19.4%
7/36 • Number of events 7 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
22.2%
8/36 • Number of events 8 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
5.6%
2/36 • Number of events 2 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Decreased Platelet count
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
|
Blood and lymphatic system disorders
Decreased Bicarbonate
|
2.8%
1/36 • Number of events 1 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
0.00%
0/36 • Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place