Trial Outcomes & Findings for PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function (NCT NCT03639610)
NCT ID: NCT03639610
Last Updated: 2023-03-10
Results Overview
Maximum observed concentration (Cmax)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.
Results posted on
2023-03-10
Participant Flow
The first patient (in Cohort 1a) received their first dose of study drug on 17 September 2018. The last patient (in Cohort 2a) received their first dose of study drug on 29 June 2021.
All enrolled patients received study treatment and were included in the Safety Analysis Set.
Participant milestones
| Measure |
Cohort 1a, Melflufen 40 mg
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
10
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
21
|
10
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1a, Melflufen 40 mg
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
1
|
0
|
|
Overall Study
Disease progression
|
8
|
5
|
3
|
|
Overall Study
Study terminated by sponsor
|
2
|
1
|
1
|
|
Overall Study
Patient request to stop treatment
|
1
|
2
|
0
|
Baseline Characteristics
PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function
Baseline characteristics by cohort
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.0 years
n=5 Participants
|
72.0 years
n=7 Participants
|
62.5 years
n=5 Participants
|
70.0 years
n=4 Participants
|
|
Age, Customized
<65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Customized
≥65 to ≤75 years
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Customized
>75 years
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
Czechia
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Baseline height
|
165.0 cm
n=5 Participants
|
169.0 cm
n=7 Participants
|
172.5 cm
n=5 Participants
|
168.0 cm
n=4 Participants
|
|
Baseline weight
|
73.00 kg
n=5 Participants
|
75.25 kg
n=7 Participants
|
85.50 kg
n=5 Participants
|
74.00 kg
n=4 Participants
|
|
Baseline Eastern Cooperative Oncology Group (ECOG) score
score = 0
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Baseline Eastern Cooperative Oncology Group (ECOG) score
score = 1
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Baseline Eastern Cooperative Oncology Group (ECOG) score
score = 2
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
International Staging System (ISS) stage at study entry
stage I
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
International Staging System (ISS) stage at study entry
stage II
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
International Staging System (ISS) stage at study entry
stage III
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
International Staging System (ISS) stage at study entry
unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Evidence of lytic bone disease at study entry
Yes
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Evidence of lytic bone disease at study entry
No
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Evidence of extramedullary disease at study entry
Yes
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Evidence of extramedullary disease at study entry
No
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Disease status at study entry
Relapsed
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Disease status at study entry
Relapsed-refractory
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Time since diagnosis
|
6.47 years
n=5 Participants
|
3.82 years
n=7 Participants
|
5.13 years
n=5 Participants
|
4.78 years
n=4 Participants
|
|
Time since most recent relapse/progression
|
1.12 months
n=5 Participants
|
1.49 months
n=7 Participants
|
3.29 months
n=5 Participants
|
1.25 months
n=4 Participants
|
|
Baseline estimated glomerular filtration rate (eGFR)
≥15 to <30 mL/min/1.73m²
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Baseline estimated glomerular filtration rate (eGFR)
≥30 to <45 mL/min/1.73m²
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Baseline estimated glomerular filtration rate (eGFR)
≥45 mL/min/1.73m²
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Cytogenetics abnormalities by interphase fluorescence in situ hybridization (iFISH) at study entry
High-risk abnormalities
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Cytogenetics abnormalities by interphase fluorescence in situ hybridization (iFISH) at study entry
Standard-risk abnormalities
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Cytogenetics abnormalities by interphase fluorescence in situ hybridization (iFISH) at study entry
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Cytogenetics abnormalities by interphase fluorescence in situ hybridization (iFISH) at study entry
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Prior autologous transplant
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Number of prior systemic therapy lines
2 prior lines of therapy
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Number of prior systemic therapy lines
3 prior lines of therapy
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Number of prior systemic therapy lines
4 prior lines of therapy
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.Population: Some patients were not evaluable for pharmacokinetics (PK) and were excluded from Cycle 1 and/or Cycle 2.
Maximum observed concentration (Cmax)
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Cmax of Melphalan
Cycle 1
|
550.1538 ng/mL
Standard Deviation 170.024
|
472.2000 ng/mL
Standard Deviation 141.505
|
181.2500 ng/mL
Standard Deviation 76.098
|
|
Cmax of Melphalan
Cycle 2
|
539.4444 ng/mL
Standard Deviation 178.246
|
469.5000 ng/mL
Standard Deviation 177.340
|
194.0000 ng/mL
Standard Deviation 57.663
|
PRIMARY outcome
Timeframe: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.Population: Some patients were not evaluable for PK and were excluded from Cycle 1 and/or Cycle 2.
Time of maximum observed concentration (Tmax)
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Tmax of Melphalan
Cycle 1
|
38.0000 minutes
Interval 35.0 to 40.0
|
40.0000 minutes
Interval 35.0 to 45.0
|
37.0000 minutes
Interval 36.0 to 40.0
|
|
Tmax of Melphalan
Cycle 2
|
37.0000 minutes
Interval 35.0 to 40.0
|
40.0000 minutes
Interval 38.0 to 40.0
|
36.0000 minutes
Interval 35.0 to 37.0
|
PRIMARY outcome
Timeframe: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.Population: Some patients were not evaluable for PK and were excluded from Cycle 1 and/or Cycle 2.
Area under the concentration-time curve (AUC) from 0h to the last measurable concentration.
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Area Under the Curve (0-t) of Melphalan
Cycle 1
|
78250.3462 minutes*ng/mL
Standard Deviation 21391.384
|
70303.4400 minutes*ng/mL
Standard Deviation 16874.787
|
27912.7125 minutes*ng/mL
Standard Deviation 10385.219
|
|
Area Under the Curve (0-t) of Melphalan
Cycle 2
|
74415.5556 minutes*ng/mL
Standard Deviation 21354.648
|
67458.0000 minutes*ng/mL
Standard Deviation 19241.040
|
32146.0000 minutes*ng/mL
Standard Deviation 5804.816
|
PRIMARY outcome
Timeframe: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.Population: Some patients were not evaluable for PK and were excluded from Cycle 1 and/or Cycle 2.
Area under the concentration-time curve (AUC) from 0 hours to infinity
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Area Under the Curve (Inf) of Melphalan
Cycle 1
|
85123.3635 minutes*ng/mL
Standard Deviation 22765.646
|
77173.0689 minutes*ng/mL
Standard Deviation 15347.431
|
31712.9042 minutes*ng/mL
Standard Deviation 11597.404
|
|
Area Under the Curve (Inf) of Melphalan
Cycle 2
|
80365.5468 minutes*ng/mL
Standard Deviation 22334.049
|
72830.2410 minutes*ng/mL
Standard Deviation 20632.358
|
39685.8277 minutes*ng/mL
Standard Deviation 6405.267
|
PRIMARY outcome
Timeframe: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.Population: Some patients were not evaluable for PK and were excluded from Cycle 1 and/or Cycle 2.
Elimination half-life of melphalan
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
T1/2 of Melphalan
Cycle 1
|
89.1390 minutes
Standard Deviation 15.575
|
98.3568 minutes
Standard Deviation 27.249
|
109.5502 minutes
Standard Deviation 22.221
|
|
T1/2 of Melphalan
Cycle 2
|
87.5544 minutes
Standard Deviation 15.860
|
90.7844 minutes
Standard Deviation 14.411
|
136.2193 minutes
Standard Deviation 13.679
|
SECONDARY outcome
Timeframe: Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (max duration 127.1 weeks).Population: This analysis was performed in the Safety Analysis Set, which is defined as all patients who received at least 1 or partial dose of melflufen or dexamethasone.
Best confirmed response required 2 consecutive assessments with the same response result made at any time. In case at the second consecutive assessment (made at any time) the response is higher than the previous one, then confirmed response (linked to the first assessment visit) will be the first one (e.g., PR - VGPR consecutive pair will lead to a PR confirmed response at the first visit). In case the second consecutive response is lower than the first one, then confirmed response (linked to the first assessment visit) will be the second one (e.g. CR-VGPR consecutive pair will lead to a VGPR confirmed response at the first visit).
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Best Confirmed Response
Stringent complete response (sCR)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Confirmed Response
Complete response (CR)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Best Confirmed Response
Very good partial response (VGPR)
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Best Confirmed Response
Partial response (PR)
|
7 Participants
|
4 Participants
|
1 Participants
|
|
Best Confirmed Response
Minimal response (MR)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Best Confirmed Response
Stable disease (SD)
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Best Confirmed Response
Progressive disease (PD)
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Best Confirmed Response
Non-evaluable
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until disease progression (confirmed on 2 consecutive assessments) (maximum duration 127.1 weeks).Population: This analysis was performed in the Safety Analysis Set, which is defined as all patients who received at least 1 or partial dose of melflufen or dexamethasone.
Overall response rate (ORR) is the percentage of patients who achieved a confirmed response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as best response, as assessed by the Investigator.
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Overall Response Rate
|
10 Participants
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Patients were assessed for response after each cycle (maximum duration 127.1 weeks).Population: This analysis was performed in the Safety Analysis Set, which is defined as all patients who received at least 1 or partial dose of melflufen or dexamethasone.
Clinical benefit rate (CBR) is the proportion of patients who achieved a confirmed minimal response (MR) or better (stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\], partial response \[PR\], and MR) as their best response, as assessed by the Investigator.
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Clinical Benefit Rate
|
11 Participants
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Patients were assessed from the initiation of therapy until documented disease progression or initiation of new therapy (maximum duration 127.1 weeks).Population: This analysis was performed in the Safety Analysis Set, which is defined as all patients who received at least 1 or partial dose of melflufen or dexamethasone.
Progression-free survival (PFS) was defined as the time from the date of first study drug (the earliest of melflufen and dexamethasone start date) initiation to the date of first documentation of confirmed PD or death due to any cause, whichever occurred first. Participants were deemed 'progressed' in case of i) unconfirmed progressive disease (PD) as the final response assessment, ii) death after at least one response assessment or PD based on at least two consecutive response assessments at any time, or iii) death before the first response assessment. The distribution of PFS was summarized using the Kaplan-Meier (K-M) method. The median PFS was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median PFS was constructed using the method of Brookmeyer (Brookmeyer, 1982).
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Progression-free Survival
|
8.61 months
Interval 4.3 to 14.52
|
7.66 months
Interval 6.24 to
Data not estimable. At the final data cut the upper limit CI was not reached at the previous data cut due to too few events
|
3.43 months
Interval 0.95 to
Data not estimable. At the final data cut the upper limit CI was not reached at the previous data cut due to too few events
|
SECONDARY outcome
Timeframe: Patients were assessed for response from the first measure of a confirmed response (PR or better) until confirmed progression, death, or initiation of subsequent therapy (maximum duration 127.1 weeks).Population: This analysis included patients who achieved a best confirmed response of PR or better.
Duration of response (DOR) is defined as the time from the first evidence of confirmed assessment of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) to first confirmed disease progression, or to death due to any cause. The distribution of DOR was summarized using the Kaplan-Meier (K-M) method. The median DOR was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median DOR was constructed using the method of Brookmeyer (Brookmeyer, 1982).
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=7 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=1 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Duration of Response
|
8.31 months
Interval 5.82 to 23.49
|
13.83 months
Interval 4.63 to
Data not estimable. At the final data cut the upper limit CI was not reached at the previous data cut due to too few events
|
NA months
Data not estimable due to an insufficient number of patients. Only one patient had a best response of confirmed PR or better
|
SECONDARY outcome
Timeframe: Patients were assessed from the first measure of a confirmed MR or better until confirmed progression, death, or initiation of subsequent therapy (maximum duration 127.1 weeks).Population: This analysis included patients who achieved a best response of MR or better.
Duration of clinical benefit (DOCB) was calculated as time in months from the first evidence of confirmed assessment of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) to first confirmed disease progression, or to death due to any cause. DOCB was defined only for patients with a confirmed MR or better. DOCB was summarized using the Kaplan-Meier (K-M) method. The median DOCB was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median DOCB was constructed using the method of Brookmeyer (Brookmeyer, 1982).
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=11 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=8 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=1 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Duration of Clinical Benefit
|
9.26 months
Interval 5.82 to 23.49
|
10.58 months
Interval 4.63 to
Data not estimable. At the final data cut the upper limit CI was not reached at the previous data cut due to too few events
|
NA months
Data not estimable due to an insufficient number of events. Only one patient had a best response of confirmed MR or better.
|
SECONDARY outcome
Timeframe: From initiation of therapy until documented disease response (maximum duration 127.1 weeks).Population: This analysis included patients who achieved a best confirmed response of PR or better.
Time from first dose of therapy to first documented confirmed response of partial response (PR) or better.
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=7 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=1 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Time to Response
|
2.45 months
Interval 1.0 to 11.3
|
1.18 months
Interval 0.9 to 7.6
|
2.83 months
Interval 2.83 to 2.83
|
SECONDARY outcome
Timeframe: Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (max duration 127.1 weeks).Population: This analysis included patients who achieved a best response of MR or better.
Time to clinical benefit was defined as the time from first dose of therapy to first documented confirmed response of minimal response (MR) or better.
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=11 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=8 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=1 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Time to Clinical Benefit
|
1.12 months
Interval 1.0 to 8.7
|
1.12 months
Interval 0.9 to 5.9
|
2.83 months
Interval 2.83 to 2.83
|
SECONDARY outcome
Timeframe: Patients were followed for overall survival until death or until the last patient in the study had documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (maximum of 39.2 months).Population: This analysis was performed in the Safety Analysis Set, which is defined as all patients who received at least 1 or partial dose of melflufen or dexamethasone.
Overall survival was defined as the time in months from initiation of therapy to death due to any cause. Patients still alive at the end of the study, or lost to follow up, were censored at last day known alive.
Outcome measures
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 Participants
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 Participants
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Overall Survival
|
9.76 months
Interval 5.06 to 15.38
|
NA months
Interval 6.83 to
Data not estimable. Death due to any cause occurred in 3 patients (as reported at both data cuts). The median and upper limit were not reached due to too few events
|
NA months
Interval 3.15 to
Data not estimable. Death due to any cause occurred in 1 patient; the patient had a survival time of 3.15 months.The median and upper limit were not reached due to too few events
|
Adverse Events
Cohort 1a, Melflufen 40 mg
Serious events: 9 serious events
Other events: 20 other events
Deaths: 16 deaths
Cohort 1b, Melflufen 30 mg
Serious events: 5 serious events
Other events: 10 other events
Deaths: 3 deaths
Cohort 2a, Melflufen 20 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 participants at risk
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 participants at risk
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 participants at risk
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
General disorders
Catheter site haemorrhage
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
General disorders
Disease progression
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
General disorders
Sudden cardiac death
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Pneumonia
|
9.5%
2/21 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Septic shock
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Sepsis
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Blood and lymphatic system disorders
Anaemia
|
19.0%
4/21 • Number of events 8 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Cardiac disorders
Cardiac failure
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Cardiac disorders
Atrial fibrillation
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Cardiac disorders
Cardiac arrest
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Cardiac disorders
Sinus node dysfunction
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Renal and urinary disorders
Acute kidney injury
|
9.5%
2/21 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Investigations
Platelet count decreased
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Product Issues
Device issue
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
Other adverse events
| Measure |
Cohort 1a, Melflufen 40 mg
n=21 participants at risk
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
|
Cohort 1b, Melflufen 30 mg
n=10 participants at risk
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
|
Cohort 2a, Melflufen 20 mg
n=4 participants at risk
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.7%
14/21 • Number of events 79 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
90.0%
9/10 • Number of events 42 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
50.0%
2/4 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Blood and lymphatic system disorders
Neutropenia
|
38.1%
8/21 • Number of events 42 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
50.0%
5/10 • Number of events 17 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
7/21 • Number of events 31 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
40.0%
4/10 • Number of events 14 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
25.0%
1/4 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.5%
2/21 • Number of events 5 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
20.0%
2/10 • Number of events 4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.0%
4/21 • Number of events 4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
25.0%
1/4 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
4/21 • Number of events 5 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
25.0%
1/4 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
30.0%
3/10 • Number of events 6 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
General disorders
Fatigue
|
19.0%
4/21 • Number of events 6 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
General disorders
Asthenia
|
9.5%
2/21 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
General disorders
Pyrexia
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
20.0%
2/10 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
25.0%
1/4 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
General disorders
Oedema peripheral
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
25.0%
1/4 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
General disorders
Oedema
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Respiratory tract infection
|
4.8%
1/21 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
40.0%
4/10 • Number of events 6 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
2/21 • Number of events 3 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
50.0%
2/4 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Lower respiratory tract infection
|
9.5%
2/21 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Pharyngitis
|
9.5%
2/21 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Infection
|
4.8%
1/21 • Number of events 3 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Myringitis
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
25.0%
1/4 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Infections and infestations
Otosalpingitis
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
25.0%
1/4 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.8%
5/21 • Number of events 6 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
25.0%
1/4 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
20.0%
2/10 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
25.0%
1/4 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Investigations
White blood cell count decreased
|
14.3%
3/21 • Number of events 8 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Investigations
Blood creatinine increased
|
9.5%
2/21 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Investigations
Neutrophil count decreased
|
9.5%
2/21 • Number of events 3 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Investigations
C-reactive protein increased
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
20.0%
2/10 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Injury, poisoning and procedural complications
Fall
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Nervous system disorders
Tremor
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Renal and urinary disorders
Chronic kidney disease
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/21 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
10.0%
1/10 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Cardiac disorders
Cardiac failure
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
|
Psychiatric disorders
Insomnia
|
4.8%
1/21 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/10 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
0.00%
0/4 • SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place