Trial Outcomes & Findings for A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients. (NCT NCT02091414)
NCT ID: NCT02091414
Last Updated: 2014-10-29
Results Overview
Percentage of participants with BPAR of greater than or equal to (≥) International Society of Heart and Lung Transplant (ISHLT) Grade III. The ISHLT graded symptoms on a scale of Grade 0 through VI. Grade 0 equals (=) no rejection. Grade IA = regional (perivascular or interstitial) infiltration and no necrosis, and grade IB = dissemination but little infiltration and no necrosis. Grade II = 1 focus of invasive infiltration with or without (+/-) associated cardiomyocyte necrosis. Grade IIIA = 2 or more foci of invasive infiltration +/- associated cardiomyocyte necrosis, and grade IIIB = diffuse inflammatory pathological changes associated with cardiomyocyte necrosis. Grade IV = diffuse, infiltrative multi-foci +/- edema; +/- hemorrhage; and +/-vasculitis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Results posted on
2014-10-29
Participant Flow
Participant milestones
| Measure |
Mycophenolate Mofetil (MMF) Plus (+) Cyclosporine A (CsA)
Participants received MMF 1.0 grams (g), capsules orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 milligrams per kilogram (mg/kg) PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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Overall Study
STARTED
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36
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Overall Study
COMPLETED
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32
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
Mycophenolate Mofetil (MMF) Plus (+) Cyclosporine A (CsA)
Participants received MMF 1.0 grams (g), capsules orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 milligrams per kilogram (mg/kg) PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
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Overall Study
Death
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2
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Baseline Characteristics
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.
Baseline characteristics by cohort
| Measure |
MMF + CsA
n=36 Participants
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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Age, Continuous
|
44.83 years
STANDARD_DEVIATION 11.89 • n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
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Sex: Female, Male
Male
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28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24Population: ITT population
Percentage of participants with BPAR of greater than or equal to (≥) International Society of Heart and Lung Transplant (ISHLT) Grade III. The ISHLT graded symptoms on a scale of Grade 0 through VI. Grade 0 equals (=) no rejection. Grade IA = regional (perivascular or interstitial) infiltration and no necrosis, and grade IB = dissemination but little infiltration and no necrosis. Grade II = 1 focus of invasive infiltration with or without (+/-) associated cardiomyocyte necrosis. Grade IIIA = 2 or more foci of invasive infiltration +/- associated cardiomyocyte necrosis, and grade IIIB = diffuse inflammatory pathological changes associated with cardiomyocyte necrosis. Grade IV = diffuse, infiltrative multi-foci +/- edema; +/- hemorrhage; and +/-vasculitis.
Outcome measures
| Measure |
MMF + CsA
n=36 Participants
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week
Week 1
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0.0 percentage of participants
Interval 0.0 to 0.0
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|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week
Week 2
|
2.78 percentage of participants
Interval 0.0 to 8.42
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Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week
Week 4
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2.78 percentage of participants
Interval 0.0 to 8.42
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Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week
Week 8
|
2.78 percentage of participants
Interval 0.0 to 8.42
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Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week
Day 1
|
0.0 percentage of participants
Interval 0.0 to 0.0
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Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week
Week 12
|
2.78 percentage of participants
Interval 0.0 to 8.42
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Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week
Week 16
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2.78 percentage of participants
Interval 0.0 to 8.42
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Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week
Week 20
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2.78 percentage of participants
Interval 0.0 to 8.42
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Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week
Week 24
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2.78 percentage of participants
Interval 0.0 to 8.42
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SECONDARY outcome
Timeframe: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24Population: ITT population
Outcome measures
| Measure |
MMF + CsA
n=36 Participants
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation
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0.0 percentage of participants
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SECONDARY outcome
Timeframe: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24Population: ITT population
Outcome measures
| Measure |
MMF + CsA
n=36 Participants
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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Percentage of Participants Requiring Use of Additional Immunosuppressants Not Specified in the Protocol Within 24 Weeks of Transplantation
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0.0 percentage of participants
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SECONDARY outcome
Timeframe: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24Population: ITT population
Outcome measures
| Measure |
MMF + CsA
n=36 Participants
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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Percentage of Participants Discontinuing Immunosuppressants (MMF) for More Than 14 Consecutive Days or 30 Cumulative Days Within 24 Weeks of Transplantation
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13.89 percentage of participants
Interval 2.02 to 25.76
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SECONDARY outcome
Timeframe: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24Population: ITT population
Outcome measures
| Measure |
MMF + CsA
n=36 Participants
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation
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0.0 percentage of participants
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SECONDARY outcome
Timeframe: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24Population: ITT population
Outcome measures
| Measure |
MMF + CsA
n=36 Participants
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment
Serum creatinine
|
47.22 percentage of participants
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Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment
BUN
|
8.33 percentage of participants
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SECONDARY outcome
Timeframe: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24Population: ITT population
Outcome measures
| Measure |
MMF + CsA
n=36 Participants
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment
Serum creatinine
|
22.22 percentage of participants
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Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment
BUN
|
16.67 percentage of participants
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SECONDARY outcome
Timeframe: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24Population: ITT population
Outcome measures
| Measure |
MMF + CsA
n=36 Participants
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment
Serum creatinine
|
16.67 percentage of participants
|
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Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment
BUN
|
2.78 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24Population: ITT population
Outcome measures
| Measure |
MMF + CsA
n=36 Participants
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment
Serum creatinine
|
13.89 percentage of participants
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Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment
BUN
|
72.22 percentage of participants
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Adverse Events
MMF + CsA
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MMF + CsA
n=36 participants at risk
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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General disorders
Multiple organ failure
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2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
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Cardiac disorders
Cardiac arrest
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2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
Other adverse events
| Measure |
MMF + CsA
n=36 participants at risk
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
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|---|---|
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Skin and subcutaneous tissue disorders
Rash
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
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Blood and lymphatic system disorders
Anemia
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5.6%
2/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
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Injury, poisoning and procedural complications
Wound complications
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5.6%
2/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
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|
Hepatobiliary disorders
Jaundice
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5.6%
2/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
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Nervous system disorders
Headache
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8.3%
3/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
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|
Nervous system disorders
Epilepsy
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
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|
Infections and infestations
Lung infection
|
11.1%
4/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
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|
Infections and infestations
Folliculitis
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
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|
Infections and infestations
Pneumonia
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Renal and urinary disorders
Impaired renal function
|
16.7%
6/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Renal and urinary disorders
Renal failure
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
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|
Psychiatric disorders
Insomnia
|
19.4%
7/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Psychiatric disorders
Dysphoria
|
11.1%
4/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
General disorders
Fever
|
8.3%
3/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
General disorders
Impaired healing
|
5.6%
2/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Elevated blood sugar
|
38.9%
14/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Elevated blood lipids
|
19.4%
7/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Elevated serum creatinine
|
19.4%
7/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Elevated alanine aminotransferase
|
19.4%
7/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Abnormal liver function tests
|
19.4%
7/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Elevated serum bilirubin
|
16.7%
6/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Leukocytosis
|
16.7%
6/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Elevated aspartate aminotransferase
|
13.9%
5/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
High blood pressure
|
5.6%
2/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Dyslipidemia
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Low blood pressure
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Increased platelet count
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Decreased serum glucose
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Increased serum albumin
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Increased heart rate
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Neutrophilic granulocytosis
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Elevated urea
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Investigations
Positive anti hepatitis B antigen
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
47.2%
17/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
2/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
38.9%
14/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
11.1%
4/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Metabolism and nutrition disorders
Hypoproteinemia
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Cardiac disorders
Tachycardia
|
22.2%
8/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Cardiac disorders
Bradycardia
|
8.3%
3/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Cardiac disorders
Premature beat
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Cardiac disorders
Palpitation
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Cardiac disorders
Ventricular fibrillation
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Gastrointestinal disorders
Constipation
|
19.4%
7/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Gastrointestinal disorders
Indigestion
|
8.3%
3/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.6%
2/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Gastrointestinal disorders
Oral ulcers
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Vascular disorders
Hypertension
|
22.2%
8/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Vascular disorders
Wound bleeding
|
5.6%
2/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Vascular disorders
Thrombus
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Vascular disorders
Perivenular inflammation
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER