Trial Outcomes & Findings for Study of Propranolol as Anti-Adhesive Therapy in Sickle Cell Disease (SCD) (NCT NCT01077921)
NCT ID: NCT01077921
Last Updated: 2015-01-22
Results Overview
The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 1 dyne/cm2
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Week 0 to 6 and week 8 to 14
Results posted on
2015-01-22
Participant Flow
Subjects were recruited from the Duke adult sickle cell clinic. Those that consented underwent a screening visit to determine eligibility. If eligible they were enrolled on the study and received study drug within 30 days of screening
Eighty-four patients were approached for the study, of those 28 declined to participate, 14 remained undecided. Forty-two patients consented. Thirthy-one of those consenting were enrolled and 27 randomized to the study.
Participant milestones
| Measure |
Propranolol-first
Cross-over study comprising treatment with propranolol for 6 weeks with a standard dose of 40 mg every 12 hrs, followed by a 2 weeks period washout, then similar treatment period with placebo followed by another 2 weeks washout period
|
Placebo-first
Cross-over study comprising treatment with placebo for 6 weeks, followed by a 2 weeks period washout, then similar treatment period with propranolol with a standard dose of 40 mg every 12 hrs., followed by another 2 weeks washout period.
|
|---|---|---|
|
First Intervention
STARTED
|
14
|
13
|
|
First Intervention
COMPLETED
|
13
|
12
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Washout
STARTED
|
13
|
12
|
|
Washout
COMPLETED
|
13
|
10
|
|
Washout
NOT COMPLETED
|
0
|
2
|
|
Second Intervention
STARTED
|
13
|
10
|
|
Second Intervention
COMPLETED
|
13
|
9
|
|
Second Intervention
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Propranolol as Anti-Adhesive Therapy in Sickle Cell Disease (SCD)
Baseline characteristics by cohort
| Measure |
Propranolol-first
n=14 Participants
Cross-over study comprising treatment with propranolol for 6 weeks with a standard dose of 40 mg every 12 hrs, followed by a 2 weeks period washout, then similar treatment period with placebo followed by another 2 weeks washout period
|
Placebo-first
n=13 Participants
Cross-over study comprising treatment with placebo for 6 weeks, followed by a 2 weeks period washout, then similar treatment period with propranolol with a standard dose of 40 mg every 12 hrs., followed by another 2 weeks washout period
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.2 years
n=99 Participants
|
26.1 years
n=107 Participants
|
30.4 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
13 participants
n=107 Participants
|
27 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 0 to 6 and week 8 to 14The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 1 dyne/cm2
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
SS RBC Adhesion (Epi -1d/cm2- vs. Sham) by Treatment
Epinephrine Treated Red blood cells
|
0 Percentage of total RBC
Standard Deviation 24.4
|
-0.3 Percentage of total RBC
Standard Deviation 20.1
|
|
SS RBC Adhesion (Epi -1d/cm2- vs. Sham) by Treatment
unstimulated cells (Sham treated)
|
7.4 Percentage of total RBC
Standard Deviation 18.7
|
2.7 Percentage of total RBC
Standard Deviation 26
|
PRIMARY outcome
Timeframe: Week 0 to 6 and week 8 to 14The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 2 dyne/cm2
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
SS RBC Adhesion (Epi -2d/cm2- vs. Sham) by Treatment
Epi-treated Red blood cells
|
0.2 Percentage of total RBC
Standard Deviation 13.8
|
-2.8 Percentage of total RBC
Standard Deviation 10.7
|
|
SS RBC Adhesion (Epi -2d/cm2- vs. Sham) by Treatment
unstimulated cells (Sham treated)
|
2.7 Percentage of total RBC
Standard Deviation 11.2
|
4.4 Percentage of total RBC
Standard Deviation 13
|
PRIMARY outcome
Timeframe: Week 0 to 6 and week 8 to 14The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 3 dyne/cm2
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
SS RBC Adhesion (Epi -3d/cm2- vs. Sham) by Treatment
Epi-treated Red blood cells
|
0.5 Percentage of total RBC
Standard Deviation 9.7
|
-2.8 Percentage of total RBC
Standard Deviation 7.5
|
|
SS RBC Adhesion (Epi -3d/cm2- vs. Sham) by Treatment
unstimulated cells (Sham treated)
|
-0.1 Percentage of total RBC
Standard Deviation 9.3
|
4.3 Percentage of total RBC
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Week 0 to 6 and week 8 to 14Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sE-selectin measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and week 8 to 14).
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
Overall Change of Plasma Levels of sE-selectin
|
-3.9 ng/ml
Standard Deviation 12.1
|
3.7 ng/ml
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Week 0 to 6 and week 8 to 14Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sP-selectin measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and weeks 8 to 14).
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
Overall Change of Plasma Levels of sP-selectin
|
-5 ng/ml
Standard Deviation 13.9
|
-12.8 ng/ml
Standard Deviation 54.8
|
SECONDARY outcome
Timeframe: Week 0 to 6 and week 8 to 14Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sICAM-1 measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and week 8 to 14)
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
Overall Change of Plasma Levels of sICAM-1
|
-6.4 ng/ml
Standard Deviation 15.3
|
5.4 ng/ml
Standard Deviation 28.5
|
SECONDARY outcome
Timeframe: Week 0 to 6 and week 8 to 14Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sVCAM-1 measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 or week 8 to 14)
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
Overall Change of Plasma Levels of sVCAM-1
|
-16.7 ng/ml
Standard Deviation 144.2
|
-7.2 ng/ml
Standard Deviation 117.7
|
SECONDARY outcome
Timeframe: Week 0 to 6 and week 8 to 14Overall change of Hemoglobin (Hgb) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
Overall Change of Hemoglobin (Hgb) Levels
|
0.2 gm/dL
Interval 0.1 to 0.5
|
-0.1 gm/dL
Interval -0.7 to 0.4
|
SECONDARY outcome
Timeframe: Week 0 to 6 and week 8 to 14Overall change of Hematocrit (Hct) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
Overall Change of Hematocrit (Hct) Levels
|
1 percentage of red blood cells
Interval 0.0 to 2.0
|
0 percentage of red blood cells
Interval -2.0 to 1.0
|
SECONDARY outcome
Timeframe: Week 0 to 6 and week 8 to 14Overall change of LDH levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
Overall Change of Lactate Dehydrogenase (LDH) Levels
|
24 IU/L
Interval -69.0 to 107.0
|
-5 IU/L
Interval -40.5 to 33.0
|
SECONDARY outcome
Timeframe: Week 0 to 6 and week 8 to 14Overall change of Oxygen Saturation (02Sat) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
Overall Change of Oxygen Saturation (02Sat) Levels
|
0 percentage of oxygen saturation
Interval 0.0 to 2.0
|
0 percentage of oxygen saturation
Interval -1.0 to 1.5
|
SECONDARY outcome
Timeframe: Week 0 to 6 and week 8 to 14Overall change of Systolic Blood Pressure levels from baseline to post intervention (Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
Overall Change of Systolic Blood Pressure Levels
|
-1.0 mmHg
Interval -4.0 to 5.0
|
-1.0 mmHg
Interval -8.0 to 5.5
|
SECONDARY outcome
Timeframe: Week 0 to 6 and week 8 to 14Overall change of Diastolic Blood Pressure levels from baseline to post intervention (Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated
Outcome measures
| Measure |
Propranolol
n=22 Participants
All subjects completing the propranolol treatment phase.
|
Placebo
n=23 Participants
All subjects completing the placebo treatment phase.
|
|---|---|---|
|
Overall Change of Diastolic Blood Pressure Levels
|
0 mmHg
Interval -4.0 to 5.0
|
-1 mmHg
Interval -7.0 to 5.0
|
Adverse Events
Propranolol
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Propranolol
n=27 participants at risk
Propranolol: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
|
Placebo
n=27 participants at risk
Placebo: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Vaso-occlusive crisis resulting in hospitalization
|
14.8%
4/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
11.1%
3/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
Other adverse events
| Measure |
Propranolol
n=27 participants at risk
Propranolol: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
|
Placebo
n=27 participants at risk
Placebo: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Cardiac disorders
Atrioventricular (AV) block
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
7.4%
2/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Cardiac disorders
Bradycardia
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Cardiac disorders
Drop in Blood Pressure
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Eye disorders
Bilateral conjunctivitis
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Gastrointestinal disorders
Abdominal Paiin
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
7.4%
2/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Gastrointestinal disorders
Abdominal cramping
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Gastrointestinal disorders
Abdominal pain and bloating
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Gastrointestinal disorders
Blood per rectum
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
7.4%
2/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Gastrointestinal disorders
Diarrhea, intermittent
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Gastrointestinal disorders
Nausea and vomiting
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
7.4%
2/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Gastrointestinal disorders
Stomach ache
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
General disorders
Extreme tiredness
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
7.4%
2/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
General disorders
Fatigue
|
14.8%
4/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
14.8%
4/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
General disorders
Feeling of internal heat
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
General disorders
Increased Fatigue
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
General disorders
Shakes
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Infections and infestations
E Coli Bacteremia
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Infections and infestations
Fever
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Infections and infestations
MRSA Positive
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Infections and infestations
Sinus Infection
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Infections and infestations
Sore throat
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
7.4%
2/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Metabolism and nutrition disorders
Sensitivity to cold
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain Crisis
|
22.2%
6/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
14.8%
4/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Back
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Bone
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Increased knee pain
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Jaw
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Joint
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Knee
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Left chest wall
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Leg
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Musculoskeletal
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
14.8%
4/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, back and chest
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
7.4%
2/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Toothache
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Vaso-occlusive Crisis
|
7.4%
2/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
7.4%
2/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Nervous system disorders
Dizziness
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
18.5%
5/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Nervous system disorders
Headache
|
29.6%
8/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
29.6%
8/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Nervous system disorders
Headache, extreme
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Psychiatric disorders
Worsening depression
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Renal and urinary disorders
Pylonephritis due to E. Coli
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Renal and urinary disorders
Smelly urine and bladder spasms
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Reproductive system and breast disorders
Delayed menstrual period
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Reproductive system and breast disorders
Prolonged menstrual period
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, Upper Chest
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
6/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing, congestion
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
14.8%
4/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing/Allergies
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Skin and subcutaneous tissue disorders
Skin abrasions due to pruritus
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Thrush
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Infections and infestations
Atypical mycoplasma pneumonia, Suspected
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Fracture, left foot
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Fatigue with chest tightness
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Hip
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Migrating
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain episode
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Right foot, plantar
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Leg, sharp shooting
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Pain, Shoulder/Chest
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Nervous system disorders
Dizziness/Vertigo
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Nervous system disorders
Headache, Intermittent
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Nervous system disorders
Lightheadness
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Nervous system disorders
Vertigo
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Cold symptoms
|
7.4%
2/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath on exertion
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat, intermittent
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
sinus allergies
|
7.4%
2/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, Sinus
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat, worsening
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
Skin and subcutaneous tissue disorders
Skin abrasions due to pruritis
|
3.7%
1/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
|
General disorders
ED Visit
|
0.00%
0/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
11.1%
3/27
All patients who were enrolled and had at least one baseline visit are included in the "at risk" category.
|
Additional Information
Laura De Castro, MD, MHSc
Duke University Medical Center
Phone: (412) 623-7026
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place