Trial Outcomes & Findings for Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas (NCT NCT03489369)
NCT ID: NCT03489369
Last Updated: 2021-02-18
Results Overview
Assess the safety, tolerability and dose-limiting toxicities of Sym022 on a Q2W schedule to establish the MTD and/or RP2D.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
19 months
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
Dose Level 1
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
6
|
Reasons for withdrawal
| Measure |
Dose Level 1
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Overall Study
Documented Progressive Disease
|
3
|
2
|
3
|
6
|
|
Overall Study
Clinical Progression (Worsening of Clini
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=3 Participants
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=3 Participants
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=3 Participants
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
n=6 Participants
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
69 years
STANDARD_DEVIATION 1.73 • n=7 Participants
|
70.3 years
STANDARD_DEVIATION 13.28 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 6.11 • n=4 Participants
|
65.4 years
STANDARD_DEVIATION 8.69 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
ECOG PS
0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
ECOG PS
1
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 19 monthsPopulation: Patients evaluable for Maximum Tolerated Dose
Assess the safety, tolerability and dose-limiting toxicities of Sym022 on a Q2W schedule to establish the MTD and/or RP2D.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=3 Participants
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=3 Participants
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
n=6 Participants
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Assessment of Treatment Related Adverse Events (AEs).
|
0 Patients with any DLT
|
0 Patients with any DLT
|
0 Patients with any DLT
|
1 Patients with any DLT
|
SECONDARY outcome
Timeframe: 19 monthsSerum sampling and incidence (%) per dose level to assess the potential for anti-drug antibody (ADA) formation. Count of participants show the number of participants who were tested positive for anti-Sym022 ADA.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=3 Participants
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=3 Participants
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
n=6 Participants
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Evaluation of the Immunogenicity of Sym022.
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 13 monthsAssessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), Response Evaluation Criteria in Lymphomas 2017 (RECIL 2017), or Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST), depending on tumor type. The numbers shown below correspond to the values related to RECIST v1.1.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=3 Participants
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=3 Participants
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
n=6 Participants
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Evaluation of Objective Response (OR) or Stable Disease (SD).
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 13 monthsBased on time of enrollment to first evidence of progression on imaging studies, as assessed by RECIST v1.1, RECIL 2017, or iRECIST, depending on tumor type. The numbers shown below correspond to the values related to RECIST v1.1.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=3 Participants
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=3 Participants
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
n=6 Participants
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Time to Progression (TTP) of Disease.
|
1.64 months
Interval 1.6 to 3.0
|
5.59 months
Interval 1.7 to 5.6
|
6.14 months
Interval 1.6 to 9.3
|
1.58 months
Interval 0.7 to 3.6
|
SECONDARY outcome
Timeframe: 19 monthsWill be estimated using non-compartmental methods and actual timepoints.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=3 Participants
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=3 Participants
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
n=6 Participants
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve in a Dosing Interval (AUC).
|
926 hours*μg/mL
Standard Deviation 151
|
3860 hours*μg/mL
Standard Deviation 1010
|
10000 hours*μg/mL
Standard Deviation 1720
|
28300 hours*μg/mL
Standard Deviation 7110
|
SECONDARY outcome
Timeframe: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)Will be derived from observed data.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=3 Participants
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=3 Participants
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
n=6 Participants
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Maximum Concentration (Cmax)
|
7.61 μg/mL
Standard Deviation 1.706
|
29.58 μg/mL
Standard Deviation 4.060
|
76.54 μg/mL
Standard Deviation 4.865
|
243.99 μg/mL
Standard Deviation 88.517
|
SECONDARY outcome
Timeframe: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)Will be derived from observed data.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=3 Participants
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=3 Participants
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
n=6 Participants
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Time to Reach Maximum Concentration (Tmax)
|
3.06 hours
Standard Deviation 2.018
|
4.52 hours
Standard Deviation 2.869
|
2.43 hours
Standard Deviation 2.271
|
1.98 hours
Standard Deviation 1.636
|
SECONDARY outcome
Timeframe: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)Will be derived from observed data.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=3 Participants
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=3 Participants
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
n=6 Participants
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Trough Concentration (Ctrough)
|
0.85 μg/mL
Standard Deviation 0.465
|
4.09 μg/mL
Standard Deviation 1.931
|
12.22 μg/mL
Standard Deviation 1.547
|
44.10 μg/mL
Standard Deviation 12.475
|
SECONDARY outcome
Timeframe: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)Population: For some participants in "Dose Level 4", the time span between the first and the last data point for the terminal rate constant did not cover at least 1.5 halflives, and these participants are therefore not part of the analysis.
Will be estimated using non-compartmental methods and actual timepoints.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=3 Participants
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=3 Participants
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
n=3 Participants
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Terminal Elimination Half-life (T½)
|
119.48 hours
Standard Deviation 33.674
|
133.12 hours
Standard Deviation 35.491
|
152.94 hours
Standard Deviation 24.570
|
169.05 hours
Standard Deviation 18.830
|
SECONDARY outcome
Timeframe: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)Population: Participants with an extrapolated AUC above 20% (for single dose administration) are not part of the analysis.
Will be estimated using non-compartmental methods and actual timepoints.
Outcome measures
| Measure |
Dose Level 1
n=2 Participants
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=1 Participants
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=2 Participants
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Clearance (CL)
|
0.32 (mL/h)/kg
Standard Deviation 0.006
|
0.31 (mL/h)/kg
Standard Deviation NA
Standard Deviation is not available since the overall number of participants analyzed is 1
|
0.24 (mL/h)/kg
Standard Deviation 0.060
|
—
|
Adverse Events
Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Level 4
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Dose Level 1
n=3 participants at risk
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=3 participants at risk
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=3 participants at risk
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
n=6 participants at risk
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
General disorders
Chest Pain
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Investigations
Lipase increased
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
Other adverse events
| Measure |
Dose Level 1
n=3 participants at risk
0.3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 2
n=3 participants at risk
1.0 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 3
n=3 participants at risk
3 mg/kg dosing of Sym022 every second week (Q2W)
|
Dose Level 4
n=6 participants at risk
10.0 mg/kg dosing of Sym022 every second week (Q2W)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
2/6 • Number of events 4 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
2/6 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
2/6 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
66.7%
2/3 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
2/6 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
2/6 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
General disorders
Chest pain
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
General disorders
Chills
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
50.0%
3/6 • Number of events 3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
General disorders
Pain
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
General disorders
Swelling
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Infections and infestations
Conjunctivitis viral
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
2/6 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Investigations
Lipase increased
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
66.7%
2/3 • Number of events 4 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 4 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
2/6 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 4 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
2/6 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
2/6 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
2/6 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
33.3%
1/3 • Number of events 2 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
16.7%
1/6 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Umbilical discharge
|
33.3%
1/3 • Number of events 1 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/3 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
0.00%
0/6 • From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist
Only treatment-emergent adverse events are presented in clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place