Trial Outcomes & Findings for Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted (NCT NCT03832114)
NCT ID: NCT03832114
Last Updated: 2024-01-30
Results Overview
Change in proteinuria assessed by ratio to baseline of UPCR derived from 24h urine collection
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Week 12
Results posted on
2024-01-30
Participant Flow
A total of 27 patients (16 patients in Cohort A and 11 patients in Cohort B) were enrolled and treated in the treatment period 1. All 27 patients completed the study and there were no patients who discontinued the study.
A total of 27 patients (16 patients in Cohort A and 11 patients in Cohort B) were enrolled and treated in the treatment period 1. All 27 patients completed the study and there were no patients who discontinued the study.
Participant milestones
| Measure |
Cohort A: Run-In Phase
Cohort A: No kidney transplant. C3G patients who have not received a kidney transplant and have reduced C3 blood levels
|
Cohort B: Run-In Phase
Cohort B: kidney transplant. C3G patients who have received a kidney transplant and have C3G recurrence
|
Cohort A: Dose Escalation/LNP023 Treatment 200 mg b.i.d
Cohort A - no kidney transplant C3G patients who have not received a kidney transplant and have reduced C3 blood levels
|
Cohort B - Dose Escalation/LNP023 Treatment 200 mg b.i.d
Cohort B - kidney transplant C3G patients who have received a kidney transplant and have C3G recurrence
|
|---|---|---|---|---|
|
Run-in Phase
STARTED
|
16
|
11
|
0
|
0
|
|
Run-in Phase
COMPLETED
|
16
|
11
|
0
|
0
|
|
Run-in Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Escalation/200mg b.i.d Treatment
STARTED
|
0
|
0
|
16
|
11
|
|
Dose Escalation/200mg b.i.d Treatment
COMPLETED
|
0
|
0
|
16
|
11
|
|
Dose Escalation/200mg b.i.d Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted
Baseline characteristics by cohort
| Measure |
Cohort A - no Kidney Transplant
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
22.0 Years
n=99 Participants
|
31.0 Years
n=107 Participants
|
24.0 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable
Change in proteinuria assessed by ratio to baseline of UPCR derived from 24h urine collection
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR)
|
0.55 ratio
Interval 0.46 to 0.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable
Histopathological changes in kidney biopsies as assessed by change from baseline in C3 Deposit Score (based on immunofluorescence microscopy)
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=7 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Cohort B: Change From Baseline in C3 Deposit
|
-2.50 Percentage change
Interval -3.75 to -0.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12: Day 84Population: Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable
Ratio to baseline UPCR derived from 24 hour urine collection
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=7 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Urine Protein Creatinine Concentration Ratio (UPCR)
|
0.55 ratio
Interval 0.46 to 0.65
|
0.79 ratio
Interval 0.49 to 1.28
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12: Day 84Population: Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable
Ratio to baseline UP excretion derived from 24 hour urine collection
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=9 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Urine Protein (UP) Excretion
|
0.57 ratio
Interval 0.47 to 0.68
|
1.00 ratio
Interval 0.75 to 1.33
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12: Day 84Population: Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable
Ratio to baseline UACR excretion derived from 24 hour urine collection
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=7 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Urine Albumin Creatinine Concentration Ratio (UACR) Excretion
|
0.55 ratio
Interval 0.47 to 0.64
|
0.61 ratio
Interval 0.3 to 1.27
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12: Day 84Population: Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable
Ratio to baseline UA excretion derived from 24 hour urine collection
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=9 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Change in Urinary Albumin (UA) Excretion
|
0.57 ratio
Interval 0.47 to 0.7
|
0.81 ratio
Interval 0.67 to 0.98
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 84Population: Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable
Effect of LNP023 on estimated glomerular filtration rate (eGFR)
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=9 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
|
2.59 ml/min
Interval 0.12 to 5.06
|
-0.61 ml/min
Interval -3.36 to 2.15
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12: Day 84Population: Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable
The effect of LNP023 on renal function - serum creatinine
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=9 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Creatinine
|
-5.04 mmol/L
Interval -9.36 to -0.72
|
7.17 mmol/L
Interval -1.79 to 16.13
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12: Day 84Population: Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable
The effect of LNP023 on renal function - creatinine clearance
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=8 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Creatinine Clearance
|
1.07 mL/min
Interval 0.99 to 1.17
|
1.20 mL/min
Interval 0.83 to 1.72
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12: Day 84Population: Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable. n: number of patients in the respective baseline category and post-baseline time point.
The effect of LNP023 on renal function - hematuria
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=9 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Hematuria
Week 12: Day 84: <9 rbc/hpf n (%)
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Hematuria
Week 12: Day 84: >= 9 to =<50 rbc/hpf n (%)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Hematuria
Week 12: Day 84: >50 rbc/hpf n (%)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 9: Day 64Population: Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable
Ratio to baseline of UPCR reduction derived from total cumulative urinary excretion first morning void
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=15 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=7 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) First Morning Void
|
0.56 ratio
Interval 0.48 to 0.65
|
0.99 ratio
Interval 0.76 to 1.28
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 9: Day 64Population: Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable
UACR reduction derived from total cumulative urinary excretion first morning void
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=15 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=7 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Urine Albumin to Creatinine Concentration Ratio (UACR) First Morning Void
|
0.59 g/mol
Interval 0.5 to 0.69
|
0.87 g/mol
Interval 0.6 to 1.26
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose)Population: PK Analysis Set: all patients with available PK data and no protocol deviations with relevant impact on PK data.
The area under the plasma concentration-time curve calculated from time zero to the last quantifiable concentration point (hr\*ng/mL)
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=15 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=16 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
n=15 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
n=9 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUClast (AUC)
|
3690 hr*ng/mL
Standard Deviation 693
|
5790 hr*ng/mL
Standard Deviation 1630
|
13200 hr*ng/mL
Standard Deviation 4410
|
20300 hr*ng/mL
Standard Deviation 8180
|
4560 hr*ng/mL
Standard Deviation 2060
|
7880 hr*ng/mL
Standard Deviation 3830
|
19600 hr*ng/mL
Standard Deviation 12100
|
28100 hr*ng/mL
Standard Deviation 15900
|
SECONDARY outcome
Timeframe: Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose)Population: PK Analysis Set: all patients with available PK data and no protocol deviations with relevant impact on PK data.
The area under the plasma concentration-time curve calculated to the end of the dosing interval (hr\*ng/mL)
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=15 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=16 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
n=15 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
n=9 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUCtau (AUC)
|
5020 hr*ng/mL
Standard Deviation 1110
|
7970 hr*ng/mL
Standard Deviation 2250
|
17800 hr*ng/mL
Standard Deviation 5800
|
26900 hr*ng/mL
Standard Deviation 10900
|
6300 hr*ng/mL
Standard Deviation 3000
|
10700 hr*ng/mL
Standard Deviation 5310
|
26600 hr*ng/mL
Standard Deviation 16500
|
37700 hr*ng/mL
Standard Deviation 22000
|
SECONDARY outcome
Timeframe: Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose)Population: PK Analysis Set: all patients with available PK data and no protocol deviations with relevant impact on PK data.
The observed maximum plasma concentration (ng/mL)
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=15 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=16 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
n=15 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
n=9 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Observed Maximum Concentration After Drug Administration (Cmax)
|
637 ng/mL
Standard Deviation 97.1
|
941 ng/mL
Standard Deviation 278
|
2270 ng/mL
Standard Deviation 805
|
3600 ng/mL
Standard Deviation 1230
|
713 ng/mL
Standard Deviation 292
|
1280 ng/mL
Standard Deviation 552
|
3250 ng/mL
Standard Deviation 1790
|
4700 ng/mL
Standard Deviation 2200
|
SECONDARY outcome
Timeframe: Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose)Population: PK Analysis Set: all patients with available PK data and no protocol deviations with relevant impact on PK data.
The concentration that is just prior to the beginning of, or at the end, of a dosing interval (ng/mL)
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=15 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=16 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
n=15 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
n=9 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Observed Minimum Concentration After Drug Administration (Ctrough)
|
314 ng/mL
Standard Deviation 133
|
519 ng/mL
Standard Deviation 133
|
1090 ng/mL
Standard Deviation 408
|
1480 ng/mL
Standard Deviation 653
|
417 ng/mL
Standard Deviation 237
|
644 ng/mL
Standard Deviation 325
|
1650 ng/mL
Standard Deviation 1010
|
2180 ng/mL
Standard Deviation 1610
|
SECONDARY outcome
Timeframe: Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose)Population: PK Analysis Set: all patients with available PK data and no protocol deviations with relevant impact on PK data.
The time to reach peak or maximum concentration (hr)
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=15 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=16 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
n=15 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
n=11 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
n=9 Participants
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach the Maximum Plasma Concentration (Tmax)
|
2.00 hr
Interval 0.8 to 6.0
|
2.00 hr
Interval 0.9 to 4.0
|
2.00 hr
Interval 0.5 to 4.0
|
2.00 hr
Interval 1.0 to 4.0
|
2.00 hr
Interval 1.0 to 4.0
|
2.00 hr
Interval 1.0 to 6.0
|
2.00 hr
Interval 1.0 to 4.0
|
2.00 hr
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Day 36, Day 64, Day 84Population: PD Analysis Set 2: included all patients with available Pharmacodynamics (PD) data and no protocol deviations with relevant impact on PD data. At each timepoint only subjects with a value at both baseline and that timepoint were included.
To assess the effect of LNP023 on alternative complement pathway hyperactivity.
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=10 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Summary of Change From Baseline Complement C3 Biomarker in Serum
Day 1 pre-dose
|
0.0 g/L
Standard Deviation 0.06
|
0.0 g/L
Standard Deviation 0.12
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Change From Baseline Complement C3 Biomarker in Serum
Day 7 - pre-dose
|
0.1 g/L
Standard Deviation 0.10
|
0.2 g/L
Standard Deviation 0.22
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Change From Baseline Complement C3 Biomarker in Serum
Day 14 - pre-dose
|
0.3 g/L
Standard Deviation 0.17
|
0.4 g/L
Standard Deviation 0.29
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Change From Baseline Complement C3 Biomarker in Serum
Day 21 - pre-dose
|
0.5 g/L
Standard Deviation 0.25
|
0.4 g/L
Standard Deviation 0.33
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Change From Baseline Complement C3 Biomarker in Serum
Day 28 - pre-dose
|
0.5 g/L
Standard Deviation 0.29
|
0.4 g/L
Standard Deviation 0.27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Change From Baseline Complement C3 Biomarker in Serum
Day 36 - pre-dose
|
0.6 g/L
Standard Deviation 0.28
|
0.4 g/L
Standard Deviation 0.32
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Change From Baseline Complement C3 Biomarker in Serum
Day 64 - pre-dose
|
0.6 g/L
Standard Deviation 0.27
|
0.4 g/L
Standard Deviation 0.26
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Change From Baseline Complement C3 Biomarker in Serum
Day 84 - pre-dose
|
0.6 g/L
Standard Deviation 0.30
|
0.5 g/L
Standard Deviation 0.26
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Day 36, Day 64, Day 84Population: PD Analysis Set 2: included all patients with available Pharmacodynamics (PD) data and no protocol deviations with relevant impact on PD data. At each timepoint only subjects with a value at both baseline and that timepoint were included
To assess the relationship between LNP023 dose and pharmacodynamic biomarker levels of blood Bb
Outcome measures
| Measure |
Cohort A - no Kidney Transplant
n=16 Participants
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
|
Cohort B - Kidney Transplant
n=10 Participants
C3G patients who have received a kidney transplant and have C3G recurrence.
|
Cohort A -no Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 100 mg b.i.d. of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort A -no Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have not received a kidney transplant and have reduced C3 blood levels. Patients received 200 mg b.i.d. of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase, and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
Cohort B - Kidney Transplant - LNP023 10mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 10 mg b.i.d.of LNP023 during the first treatment week (Week 1) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 25 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 25 mg b.i.d.of LNP023 during the second treatment week (Week 2) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 100 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 100 mg b.i.d.of LNP023 during the third treatment week (Week 3) of the dose escalation phase
|
Cohort B - Kidney Transplant - LNP023 200 mg b.i.d.
C3G patients who have received a kidney transplant and have C3G recurrence. Patients received 200 mg b.i.d.of LNP023 during the fourth treatment week (Week 4) of the dose escalation phase and continued receiving 200 mg b.i.d. for additional 8 weeks (Patients received 200 mg b.i.d. of LNP023 a total of 9 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Ratio to Baseline Summary of Plasma Bb
Day 28 pre-dose
|
90.2 Ratio of plasma Bb
Standard Deviation 46.24
|
71.5 Ratio of plasma Bb
Standard Deviation 29.52
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ratio to Baseline Summary of Plasma Bb
Day 36 pre-dose
|
102.5 Ratio of plasma Bb
Standard Deviation 54.06
|
65.9 Ratio of plasma Bb
Standard Deviation 31.20
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ratio to Baseline Summary of Plasma Bb
Day 1 pre-dose
|
101.8 Ratio of plasma Bb
Standard Deviation 45.18
|
109.7 Ratio of plasma Bb
Standard Deviation 34.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ratio to Baseline Summary of Plasma Bb
Day 7 pre-dose
|
102.4 Ratio of plasma Bb
Standard Deviation 40.47
|
83.6 Ratio of plasma Bb
Standard Deviation 27.73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ratio to Baseline Summary of Plasma Bb
Day 14 pre-dose
|
104.4 Ratio of plasma Bb
Standard Deviation 43.35
|
81.8 Ratio of plasma Bb
Standard Deviation 39.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ratio to Baseline Summary of Plasma Bb
Day 21 pre-dose
|
97.0 Ratio of plasma Bb
Standard Deviation 58.06
|
66.4 Ratio of plasma Bb
Standard Deviation 22.95
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ratio to Baseline Summary of Plasma Bb
Day 64 pre-dose
|
116.8 Ratio of plasma Bb
Standard Deviation 59.76
|
73.2 Ratio of plasma Bb
Standard Deviation 29.62
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ratio to Baseline Summary of Plasma Bb
Day 84 pre-dose
|
116.6 Ratio of plasma Bb
Standard Deviation 57.85
|
76.3 Ratio of plasma Bb
Standard Deviation 35.84
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort A - Run-in Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort A - Dose Escalation Phase
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort A - LNP023 200mg b.i.d
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort B - Run-in Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B - Dose Escalation Phase
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort B - LNP023 200mg b.i.d
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A - Run-in Phase
n=16 participants at risk
No Kidney Transplant- C3G patients who have not received a kidney transplant and have reduced C3 blood levels
|
Cohort A - Dose Escalation Phase
n=16 participants at risk
No Kidney Transplant- C3G patients who have not received a kidney transplant and have reduced C3 blood levels
|
Cohort A - LNP023 200mg b.i.d
n=16 participants at risk
No Kidney Transplant- C3G patients who have not received a kidney transplant and have reduced C3 blood levels
|
Cohort B - Run-in Phase
n=11 participants at risk
Kidney Transplant- C3G patients who have received a kidney transplant and have C3G recurrence
|
Cohort B - Dose Escalation Phase
n=11 participants at risk
Kidney Transplant- C3G patients who have received a kidney transplant and have C3G recurrence
|
Cohort B - LNP023 200mg b.i.d
n=11 participants at risk
Kidney Transplant- C3G patients who have received a kidney transplant and have C3G recurrence
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
Other adverse events
| Measure |
Cohort A - Run-in Phase
n=16 participants at risk
No Kidney Transplant- C3G patients who have not received a kidney transplant and have reduced C3 blood levels
|
Cohort A - Dose Escalation Phase
n=16 participants at risk
No Kidney Transplant- C3G patients who have not received a kidney transplant and have reduced C3 blood levels
|
Cohort A - LNP023 200mg b.i.d
n=16 participants at risk
No Kidney Transplant- C3G patients who have not received a kidney transplant and have reduced C3 blood levels
|
Cohort B - Run-in Phase
n=11 participants at risk
Kidney Transplant- C3G patients who have received a kidney transplant and have C3G recurrence
|
Cohort B - Dose Escalation Phase
n=11 participants at risk
Kidney Transplant- C3G patients who have received a kidney transplant and have C3G recurrence
|
Cohort B - LNP023 200mg b.i.d
n=11 participants at risk
Kidney Transplant- C3G patients who have received a kidney transplant and have C3G recurrence
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Spider vein
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Chest pain
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 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%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Blood luteinising hormone increased
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Body temperature increased
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
18.2%
2/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 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%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 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)
Skin papilloma
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
18.2%
2/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
1/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.2%
1/16 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/11 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 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 the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER