Trial Outcomes & Findings for Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (NCT NCT03194776)
NCT ID: NCT03194776
Last Updated: 2021-01-05
Results Overview
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign, including abnormal laboratory findings, symptom or disease) in a participant after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any AE which is is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect in offspring, requires inpatient hospitalization or prolongation of existing hospitalization and is is medically significant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Up to 32 Weeks
Results posted on
2021-01-05
Participant Flow
A total of 46 subjects with clinical evidence of PAD and intermittent claudication were enrolled and randomized in this study.
Participant milestones
| Measure |
LLG783 6mg/kg
Participants received LLG783 6 milligram per kilogram (mg/kg) as intravenous (IV) infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication
Baseline characteristics by cohort
| Measure |
LLG783 6mg/kg
n=23 Participants
Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
n=23 Participants
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
66.7 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Maximum walking distance (MWD)
|
317.3 meters
STANDARD_DEVIATION 62.0 • n=5 Participants
|
311.3 meters
STANDARD_DEVIATION 84.0 • n=7 Participants
|
314.3 meters
STANDARD_DEVIATION 73.0 • n=5 Participants
|
|
Pain Free Walking Distance (PWFD)
|
160.7 meters
STANDARD_DEVIATION 79.4 • n=5 Participants
|
156.0 meters
STANDARD_DEVIATION 86.7 • n=7 Participants
|
158.3 meters
STANDARD_DEVIATION 82.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 32 WeeksPopulation: Safety analysis set included all participants that received any study treatment.
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign, including abnormal laboratory findings, symptom or disease) in a participant after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any AE which is is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect in offspring, requires inpatient hospitalization or prolongation of existing hospitalization and is is medically significant.
Outcome measures
| Measure |
LLG783 6mg/kg
n=23 Participants
Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
n=23 Participants
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths
AEs
|
18 Participants
|
17 Participants
|
|
Number of Participants With Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths
Drug-related AEs
|
4 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths
SAEs
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths
Death
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16 (Day 113)Population: Pharmacodynamic (PD) analysis set included all participants with available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this endpoint.
MWD was assessed by the 6MWT prior to dosing was used to evaluate functional capacity of peripheral artery disease (PAD) participants. 6MWT test included measurement of total distance walked in 6 minutes.
Outcome measures
| Measure |
LLG783 6mg/kg
n=22 Participants
Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
n=19 Participants
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Maximum Walking Distance (MWD) as Assessed by 6-minute Walk Test (6MWT) at Week 16
|
19.10 meter (m)
Interval 5.3 to 32.9
|
36.84 meter (m)
Interval 21.99 to 51.7
|
SECONDARY outcome
Timeframe: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose and 1, 2 and 4 hours postdose on Day 85Population: PK analysis set: Participants with at least 1 available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data. N (overall number of participants analyzed) = participants evaluable for this outcome measure and 'n' (number analyzed) = participants evaluable at specified time points.
AUCinf is defined as the area under the serum concentration-time curve from time zero to infinity.
Outcome measures
| Measure |
LLG783 6mg/kg
n=20 Participants
Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)
Day 1
|
2110 day*microgram per millileter (day*mg/mL)
Geometric Coefficient of Variation 21.1
|
—
|
|
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)
Day 85
|
4860 day*microgram per millileter (day*mg/mL)
Geometric Coefficient of Variation 39.1
|
—
|
SECONDARY outcome
Timeframe: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85Population: Pharmacokinetic (PK) analysis set included all participants with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
AUClast is defined as the area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration.
Outcome measures
| Measure |
LLG783 6mg/kg
n=23 Participants
Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
Day 1
|
1660 day*mcg/mL
Geometric Coefficient of Variation 33.6
|
—
|
|
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
Day 85
|
4930 day*mcg/mL
Geometric Coefficient of Variation 38.9
|
—
|
SECONDARY outcome
Timeframe: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85Population: PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
AUC(0-t)is defined as the area under the serum concentration-time curve from time zero to time 't' where is a defined time point after administration.
Outcome measures
| Measure |
LLG783 6mg/kg
n=23 Participants
Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero to Defined Time Point 't' (AUC[0-t])
Day 1
|
1640 day*mcg/mL
Geometric Coefficient of Variation 34.1
|
—
|
|
Area Under the Serum Concentration-time Curve From Time Zero to Defined Time Point 't' (AUC[0-t])
Day 85
|
3130 day*mcg/mL
Geometric Coefficient of Variation 34.7
|
—
|
SECONDARY outcome
Timeframe: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85AUCtau is defined as the area under the serum concentration-time curve from time zero to the end of the dosing interval tau.
Outcome measures
| Measure |
LLG783 6mg/kg
n=23 Participants
Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)
Day 1
|
1640 day*mcg/mL
Geometric Coefficient of Variation 34.1
|
—
|
|
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)
Day 85
|
3130 day*mcg/mL
Geometric Coefficient of Variation 34.7
|
—
|
SECONDARY outcome
Timeframe: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85Population: PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Cmax is defined as the observed maximum serum concentration following drug administration.
Outcome measures
| Measure |
LLG783 6mg/kg
n=23 Participants
Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
|---|---|---|
|
Observed Maximum Serum Concentration (Cmax) Following Drug Administration
Day 1
|
203 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 40.0
|
—
|
|
Observed Maximum Serum Concentration (Cmax) Following Drug Administration
Day 85
|
268 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 39.8
|
—
|
SECONDARY outcome
Timeframe: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85Population: PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Tmax is defined as the time to reach the maximum concentration after drug administration.
Outcome measures
| Measure |
LLG783 6mg/kg
n=23 Participants
Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
|---|---|---|
|
Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Day 1
|
0.0833 Days
Interval 0.0417 to 3.01
|
—
|
|
Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Day 85
|
0.0833 Days
Interval 0.0431 to 9.94
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16 (Day 113)Population: PD analysis set included all participants with available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
PFWD was defined as the distance walked up to the point of onset of claudication symptoms (pain) recorded during the 6MWT and was used to evaluate symptomatic functional capacity of PAD participants. The PFWD was measured as the distance walked up to the time/place where the participant first experiences symptoms typical of their claudication which included pain, cramps, or other discomfort in the buttocks, thighs, calves or feet that occurs during the 6MWT exercise period.
Outcome measures
| Measure |
LLG783 6mg/kg
n=22 Participants
Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
n=19 Participants
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Pain-free Walking Distance (PFWD) as Assessed by 6-minute Walk Test at Week 16
|
44.77 meters
Interval 20.52 to 69.02
|
57.09 meters
Interval 30.97 to 83.22
|
Adverse Events
LLG783 i.v. 6 mg/kg
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LLG783 i.v. 6 mg/kg
n=23 participants at risk
Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
n=23 participants at risk
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
Other adverse events
| Measure |
LLG783 i.v. 6 mg/kg
n=23 participants at risk
Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
Placebo
n=23 participants at risk
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Atrial flutter
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
8.7%
2/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Pericardial effusion
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
3/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Toothache
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Fatigue
|
8.7%
2/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Medical device site irritation
|
13.0%
3/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Oedema peripheral
|
8.7%
2/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Peripheral swelling
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Bronchitis
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Cystitis
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Infected bite
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Nasopharyngitis
|
21.7%
5/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
17.4%
4/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Paronychia
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Root canal infection
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Tooth abscess
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Blood creatinine increased
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Blood pressure increased
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Weight increased
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
8.7%
2/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Neuralgia
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
8.7%
2/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Sciatica
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Syncope
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
13.0%
3/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Spider vein
|
4.3%
1/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/23 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER