Trial Outcomes & Findings for Epoprostenol for Injection in Pulmonary Arterial Hypertension (NCT NCT01105091)
NCT ID: NCT01105091
Last Updated: 2025-02-04
Results Overview
The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Day 1
Results posted on
2025-02-04
Participant Flow
The study was conducted at seven Pulmonary Hypertension centers in the U.S. Patients were recruited from these Pulmonary Hypertension medical clinics. Recruitment period was March 2010 through March 2011.
Up to 14 days screening period.
Participant milestones
| Measure |
ACT-385781A (Epoprostenol for Injection)
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
ACT-385781A (Epoprostenol for Injection)
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
Baseline Characteristics
Epoprostenol for Injection in Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=20 Participants
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=10 Participants
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 17.0 • n=99 Participants
|
44.1 years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
44.7 years
STANDARD_DEVIATION 15.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
10 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class I
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class II
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class III
|
17 participants
n=99 Participants
|
8 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class IV
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.
The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.
Outcome measures
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=15 Participants
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=6 Participants
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 2 ng/kg/Min
|
98.0 (pg/ml)/(ng/kg/min)
Interval 12.5 to 416.5
|
83.1 (pg/ml)/(ng/kg/min)
Interval 36.0 to 158.5
|
PRIMARY outcome
Timeframe: Day 1Population: A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.
The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.
Outcome measures
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=10 Participants
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=6 Participants
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 4 ng/kg/Min
|
90.9 (pg/ml)/(ng/kg/min)
Interval 29.3 to 195.0
|
59.6 (pg/ml)/(ng/kg/min)
Interval 24.9 to 170.5
|
PRIMARY outcome
Timeframe: Day 1Population: A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.
The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.
Outcome measures
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=15 Participants
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=6 Participants
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 2 ng/kg/Min
|
85.5 (pg/ml)/(ng/kg/min)
Interval 12.5 to 374.5
|
109.2 (pg/ml)/(ng/kg/min)
Interval 38.4 to 152.0
|
PRIMARY outcome
Timeframe: Day 1Population: A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.
The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.
Outcome measures
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=10 Participants
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=6 Participants
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 4 ng/kg/Min
|
93.1 (pg/ml)/(ng/kg/min)
Interval 29.8 to 457.5
|
95.0 (pg/ml)/(ng/kg/min)
Interval 33.3 to 201.0
|
PRIMARY outcome
Timeframe: Baseline and 28 days (+3 days)Population: Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.
The 6-minute walk test (6MWT) was to be performed prior to initiating study treatment either during the screening visit or on Day 1 prior to drug initiation, and Day 28 (End of treatment (EOT)). This assessment is a non-encouraged test that measures the distance walked for a duration of 6 minutes. The 6MWD was recorded in the Case Report Form (CRF).
Outcome measures
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=17 Participants
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=10 Participants
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Six-minute Walk Distance (6MWD) - Baseline and Day 28
Baseline
|
339.0 meters
Full Range 84 • Interval 45.0 to 465.0
|
302.5 meters
Full Range 58.8 • Interval 25.0 to 413.0
|
|
Six-minute Walk Distance (6MWD) - Baseline and Day 28
Day 28
|
288.0 meters
Interval 114.0 to 506.0
|
323.5 meters
Interval 90.0 to 429.0
|
PRIMARY outcome
Timeframe: From baseline to 28 days (+3 days)Population: Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.
Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
Outcome measures
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=18 Participants
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=10 Participants
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Patients With New York Heart Association (NYHA) Functional Class Change (Improved or Worsened) From Baseline to Day 28
Improved Patients
|
6 participants
|
3 participants
|
|
Patients With New York Heart Association (NYHA) Functional Class Change (Improved or Worsened) From Baseline to Day 28
Worsened Patients
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline and 28 daysPopulation: Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.
Central venous blood oxygen saturation assessment was performed only in specific centers. Measurements for ScVO2 were performed during the inpatient hospitalization period on Day 1 (prior to drug initiation) and on Day 28 (EOT). Samples for ScVO2 were obtained by aspirating blood from the indwelling central venous catheter. After the sample had been drawn, the catheter was primed with study drug in order to refill the lumen to avoid interruption in treatment and sudden decompensation.
Outcome measures
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=11 Participants
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=6 Participants
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Percentage Central Venous Blood Oxygen Saturation (ScVO2) - Baseline and Day 28
Baseline
|
63.0 percentage oxygen saturation
Interval 55.0 to 78.0
|
61.5 percentage oxygen saturation
Interval 41.0 to 65.0
|
|
Percentage Central Venous Blood Oxygen Saturation (ScVO2) - Baseline and Day 28
Day 28
|
58.0 percentage oxygen saturation
Interval 36.0 to 73.0
|
56.0 percentage oxygen saturation
Interval 50.0 to 64.0
|
PRIMARY outcome
Timeframe: Baseline and 28 daysPopulation: Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.
Blood pressure (systolic and diastolic) were measured indirectly using an automatic oscillometric device, on the same arm for each measurement. The Blood Pressure was assessed at baseline and at Day 28 (End of Study Treatment visit).
Outcome measures
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=18 Participants
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=10 Participants
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Blood Pressure - Baseline and Day 28
Systolic Blood Pressure (Baseline)
|
106.5 mm Hg
Interval 81.0 to 138.0
|
106.5 mm Hg
Interval 79.0 to 142.0
|
|
Blood Pressure - Baseline and Day 28
Systolic Blood Pressure (Day 28)
|
117.5 mm Hg
Interval 98.0 to 140.0
|
116.0 mm Hg
Interval 80.0 to 136.0
|
|
Blood Pressure - Baseline and Day 28
Diastolic Blood Pressure (Baseline)
|
62.0 mm Hg
Interval 44.0 to 98.0
|
68.0 mm Hg
Interval 58.0 to 99.0
|
|
Blood Pressure - Baseline and Day 28
Diastolic Blood Pressure (Day 28))
|
71.0 mm Hg
Interval 62.0 to 84.0
|
73.0 mm Hg
Interval 60.0 to 107.0
|
PRIMARY outcome
Timeframe: Baseline and 28 daysPopulation: Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.
Heart rate was measured indirectly using an automatic oscillometric device, on the same arm for each measurement. The Heart Rate was assessed at Baseline and at Day 28 (End of Study Treatment visit).
Outcome measures
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=18 Participants
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=10 Participants
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Heart Rate - Baseline and Day 28
Baseline
|
83.0 Beats per minute
Interval 61.0 to 104.0
|
77.5 Beats per minute
Interval 60.0 to 105.0
|
|
Heart Rate - Baseline and Day 28
Day 28
|
85.0 Beats per minute
Interval 62.0 to 150.0
|
88.0 Beats per minute
Interval 76.0 to 112.0
|
PRIMARY outcome
Timeframe: Baseline and 28 daysPopulation: Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.
Body weight was measured both at baseline and day 28.
Outcome measures
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=18 Participants
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=10 Participants
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Body Weight - Baseline and Day 28
Baseline
|
74.1 kg
Interval 54.0 to 111.0
|
74.2 kg
Interval 58.0 to 103.0
|
|
Body Weight - Baseline and Day 28
Day 28
|
73.6 kg
Interval 54.0 to 102.0
|
73.3 kg
Interval 56.0 to 99.0
|
Adverse Events
ACT-385781A (Epoprostenol for Injection)
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Flolan® (Epoprostenol Sodium) for Injection
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=20 participants at risk
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=10 participants at risk
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Hepatobiliary disorders
Ascites
|
—
0/0 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
—
0/0 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Infections and infestations
Catheter Site Infection
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Hepatobiliary disorders
Cholestasis
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Infections and infestations
Device Related Sepsis
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Renal and urinary disorders
Renal Failure Acute
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Cardiac disorders
Right Ventricular Failure
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
10.0%
2/20 • Number of events 2 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Nervous system disorders
Syncope
|
10.0%
2/20 • Number of events 2 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Cardiac disorders
Ventricular Tachycardia
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
Other adverse events
| Measure |
ACT-385781A (Epoprostenol for Injection)
n=20 participants at risk
The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
|
Flolan® (Epoprostenol Sodium) for Injection
n=10 participants at risk
The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Adverse Drug Reaction
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Gastrointestinal disorders
Application Site Pruritus
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Application site Hypersensitivity
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • Number of events 2 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Catheter Site Discharge
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Catheter Site Pruritus
|
0.00%
0/20 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Catheter Site Rash
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Catheter Site Related Reaction
|
0.00%
0/20 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • Number of events 3 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • Number of events 3 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
6/20 • Number of events 6 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
70.0%
7/10 • Number of events 7 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • Number of events 3 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.0%
3/20 • Number of events 3 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Fatigue
|
15.0%
3/20 • Number of events 3 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Feeling Jittery
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Vascular disorders
Flushing
|
45.0%
9/20 • Number of events 9 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
30.0%
3/10 • Number of events 3 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Metabolism and nutrition disorders
Gout
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Investigations
Haemoglobin Decreased
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Nervous system disorders
Headache
|
65.0%
13/20 • Number of events 13 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
100.0%
10/10 • Number of events 10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Investigations
Hepatic Enzyme Increased
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/20 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Infections and infestations
Implant Site Infection
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Infusion Site Vesicles
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Investigations
International Normalised Ratio Increased
|
10.0%
2/20 • Number of events 2 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
2/20 • Number of events 2 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Localised oedema
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Medical Device Complication
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscloskeletal Chest Pain
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
10/20 • Number of events 10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
70.0%
7/10 • Number of events 7 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Oedema Peripheral
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
10.0%
2/20 • Number of events 2 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
General disorders
Pain
|
0.00%
0/20 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
15.0%
3/20 • Number of events 3 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
30.0%
3/10 • Number of events 3 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
75.0%
15/20 • Number of events 15 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
100.0%
10/10 • Number of events 10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
10.0%
2/20 • Number of events 2 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
3/20 • Number of events 3 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Renal and urinary disorders
Renal Failure Acute
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Infections and infestations
Rhinitis
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.0%
3/20 • Number of events 3 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Infections and infestations
Tooth Abscess
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Investigations
Tropinin Increased
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/20 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 3 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
30.0%
3/10 • Number of events 3 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
5.0%
1/20 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
0.00%
0/10 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
10.0%
1/10 • Number of events 1 • Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
The assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
|
Additional Information
Wade Benton, PharmD, Director of Medical Affairs
Actelion Pharmaceuticals, US
Phone: 650-808-6562
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place