Trial Outcomes & Findings for Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma (NCT NCT01988493)
NCT ID: NCT01988493
Last Updated: 2022-08-24
Results Overview
Dose limiting toxicity (DLT) was defined as toxicities at any dose level and judged to be related to the study treatment by investigator and/or the sponsor. DLTs included Grade 4 neutropenia for more than 7 days; Grade greater than or equal to (\>=) 3 febrile neutropenia for more than 1 day; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with non-traumatic bleeding; Grade \>= 3 uncontrolled nausea/vomiting and/or diarrhea despite adequate and optimal treatment and Grade \>= 3 any non-hematological adverse event (AE), except the aforementioned gastrointestinal events and alopecia. Number of participants who experienced DLT during phase 1b were reported.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
117 participants
Primary outcome timeframe
Day 1 to Day 21 of Cycle 1 (each cycle is 21 days)
Results posted on
2022-08-24
Participant Flow
First participant enrolled 06 Jan 2014. Last participant last visit: 03 Dec 2020.
A total of 27 participants were enrolled in Phase 1b part of the study and a total of 90 participants were enrolled in phase 2 part of the study. Participants enrolled in phase 1b were not eligible for randomization in phase 2.
Participant milestones
| Measure |
Phase 1b: Tepotinib 300 mg
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 2: Tepotinib
Participants randomized to receive Tepotinib recommended Phase 2 dose (RP2D) determined from Phase 1b over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 2 Sorafenib
Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
14
|
6
|
45
|
45
|
|
Overall Study
Treated
|
7
|
14
|
6
|
45
|
44
|
|
Overall Study
Safety Population
|
7
|
14
|
6
|
45
|
44
|
|
Overall Study
COMPLETED
|
7
|
14
|
6
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Phase 1b: Tepotinib 300 mg
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 2: Tepotinib
Participants randomized to receive Tepotinib recommended Phase 2 dose (RP2D) determined from Phase 1b over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 2 Sorafenib
Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|---|---|
|
Overall Study
Randomized but not treated
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Phase 1b: Tepotinib 300 mg
n=7 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 2: Tepotinib
n=45 Participants
Participants randomized to receive Tepotinib recommended Phase 2 dose (RP2D) determined from Phase 1b over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 2 Sorafenib
n=44 Participants
Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
93 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
105 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
116 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
116 Participants
n=10 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
|
0 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
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
|
0 Participants
n=10 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
|
0 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 21 of Cycle 1 (each cycle is 21 days)Population: Dose Limiting Toxicity (DLT) set included all participants who experienced a DLT during Cycle 1, or received at least 80 percent of all planned doses of treatment during Cycle.
Dose limiting toxicity (DLT) was defined as toxicities at any dose level and judged to be related to the study treatment by investigator and/or the sponsor. DLTs included Grade 4 neutropenia for more than 7 days; Grade greater than or equal to (\>=) 3 febrile neutropenia for more than 1 day; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with non-traumatic bleeding; Grade \>= 3 uncontrolled nausea/vomiting and/or diarrhea despite adequate and optimal treatment and Grade \>= 3 any non-hematological adverse event (AE), except the aforementioned gastrointestinal events and alopecia. Number of participants who experienced DLT during phase 1b were reported.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=6 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=12 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=5 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Number of Participants Experiencing Dose Limiting Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeksPopulation: The safety analysis set included all participants who had received any dose of the study medication.
An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and assessed up to 94 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=7 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Any TEAE
|
7 Participants
|
14 Participants
|
6 Participants
|
|
Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Any Serious TEAE
|
2 Participants
|
9 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From randomization to date of the observation of radiological progressive disease, assessed up to maximum 3.8 yearsPopulation: The modified intent-to treat (mITT) analysis set in the Phase 2 part of this study included all participants with Mesenchymal-epithelial transition (MET)+ hepatocelluar carcinoma (HCC) who were randomized to study treatment.
TTP was defined as the time in months from randomization to date of the observation of radiological progressive disease (PD) (based on Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1) assessed by an IRC. PD is defined as at least 20 percent (%) increase in sum of diameters of target lesions, taking as reference as smallest sum on study; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must demonstrate an absolute increase of at least 5 millimeter (mm).
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=38 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=37 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 2: Time to Progression (TTP) Based on Tumor Assessment by an Independent Review Committee (IRC)
|
2.9 Months
Interval 2.7 to 5.3
|
1.4 Months
Interval 1.4 to 1.6
|
—
|
SECONDARY outcome
Timeframe: Up to 2.8 yearsPopulation: The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.
Progression-free survival (PFS) time was defined as the time in months from randomization to either first observation of disease progression (based on RECIST v1.1) or occurrence of death due to any cause within 84 days of either randomization or the last tumor assessment. PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter(mm). PFS was measured using Kaplan-Meier (KM) estimates.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=38 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=37 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 2: Progression Free Survival (PFS) Time Based on Tumor Assessment by the Independent Review Committee (IRC)
|
2.8 Months
Interval 1.4 to 4.2
|
1.4 Months
Interval 1.4 to 1.6
|
—
|
SECONDARY outcome
Timeframe: Time from randomization to the date of death or up to 6.9 yearsPopulation: The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.
Overall survival time was measured as time in months between the date of randomization and the date of death.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=38 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=37 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 2: Overall Survival (OS)
|
9.3 Months
Interval 5.9 to 17.9
|
8.6 Months
Interval 6.4 to 9.8
|
—
|
SECONDARY outcome
Timeframe: From randomization to date of the observation of radiological progressive disease, assessed up to maximum 2.8 yearsPopulation: The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.
TTP was defined as the time in months from randomization to date of the observation of radiological PD (based on RECIST v1.1) assessed by the investigator. PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=38 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=37 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 2: Time to Progression (TTP) Based on Tumor Assessment by Investigator
|
5.6 Months
Interval 3.0 to 7.6
|
2.8 Months
Interval 1.5 to 2.8
|
—
|
SECONDARY outcome
Timeframe: Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)Population: The Pharmacokinetic (PK) analysis included all participants who had received at least 1 dose of Tepotinib and who had provided at least 1 plasma concentration measurement of Tepotinib after the first dose.
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=7 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Tepotinib
Day 1
|
NA nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, AUC(0-inf) dependent on Lambda(z) were not determined.
|
NA nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, AUC(0-inf) dependent on Lambda(z) were not determined.
|
NA nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, AUC(0-inf) dependent on Lambda(z) were not determined.
|
|
Phase 1b: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Tepotinib
Day 15
|
NA nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, AUC(0-inf) dependent on Lambda(z) were not determined.
|
NA nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, AUC(0-inf) dependent on Lambda(z) were not determined.
|
NA nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, AUC(0-inf) dependent on Lambda(z) were not determined.
|
SECONDARY outcome
Timeframe: Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)Population: The PK analysis set was used. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at each specified time point.
Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLLQ). AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=5 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of Tepotinib
Day 1 of Cycle 1
|
4700 ng*h/mL
Geometric Coefficient of Variation 12.1
|
6760 ng*h/mL
Geometric Coefficient of Variation 28.0
|
11900 ng*h/mL
Geometric Coefficient of Variation 40.3
|
|
Phase 1b: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of Tepotinib
Day 15 of Cycle 1
|
11800 ng*h/mL
Geometric Coefficient of Variation 35.7
|
16700 ng*h/mL
Geometric Coefficient of Variation 29.7
|
28600 ng*h/mL
Geometric Coefficient of Variation 38.8
|
SECONDARY outcome
Timeframe: Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)Population: The PK analysis set was used. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at each specified time point.
AUC (0-tau) is the area under the plasma concentration time curve within 1 dosing interval.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=5 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Area Under the Plasma Concentration-Time Curve Within 1 Dosing Interval (AUC 0-tau) of Tepotinib
Day 1 of Cycle 1
|
4700 ng*h/mL
Geometric Coefficient of Variation 12.1
|
6760 ng*h/mL
Geometric Coefficient of Variation 28.0
|
11900 ng*h/mL
Geometric Coefficient of Variation 40.3
|
|
Phase 1b: Area Under the Plasma Concentration-Time Curve Within 1 Dosing Interval (AUC 0-tau) of Tepotinib
Day 15 of Cycle 1
|
11800 ng*h/mL
Geometric Coefficient of Variation 35.7
|
16700 ng*h/mL
Geometric Coefficient of Variation 29.7
|
28600 ng*h/mL
Geometric Coefficient of Variation 38.8
|
SECONDARY outcome
Timeframe: Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)Population: The PK analysis set was used. Here "Number Analyzed" signifies those participants who were evaluable for specified time point.
Cmax is the maximum observed plasma concentration obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=7 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Maximum Observed Plasma Concentration (Cmax) of Tepotinib
Day 1 of Cycle 1
|
266 ng/mL
Geometric Coefficient of Variation 24.7
|
394 ng/mL
Geometric Coefficient of Variation 30.4
|
680 ng/mL
Geometric Coefficient of Variation 44.0
|
|
Phase 1b: Maximum Observed Plasma Concentration (Cmax) of Tepotinib
Day 15 of Cycle 1
|
585 ng/mL
Geometric Coefficient of Variation 30.8
|
815 ng/mL
Geometric Coefficient of Variation 31.6
|
1370 ng/mL
Geometric Coefficient of Variation 36.3
|
SECONDARY outcome
Timeframe: Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 15 of Cycle 1 (each Cycle is 21 days)Population: The PK analysis set was used. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Cmin is minimum observed plasma concentration obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=5 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=11 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Minimum Observed Plasma Concentration (Cmin) of Tepotinib
|
398 ng/mL
Geometric Coefficient of Variation 39.0
|
529 ng/mL
Geometric Coefficient of Variation 43.6
|
1010 ng/mL
Geometric Coefficient of Variation 38.8
|
SECONDARY outcome
Timeframe: Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 15 of Cycle 1 (each Cycle is 21 days)Population: The PK analysis set was used. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Cavg is the average plasma concentration within 1 dosing interval obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=5 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=11 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Average Observed Plasma Concentration (Cav) of Tepotinib
|
494 ng/mL
Geometric Coefficient of Variation 35.7
|
696 ng/mL
Geometric Coefficient of Variation 29.7
|
1190 ng/mL
Geometric Coefficient of Variation 38.8
|
SECONDARY outcome
Timeframe: Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)Population: The PK analysis set was used. Here "Number Analyzed" signifies those participants who were evaluable for specified time point.
Tmax is time to reach maximum observed plasma concentration obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=7 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Time to Reach Maximum Plasma Concentration (Tmax) of Tepotinib
Day 1 of Cycle 1
|
8.00 Hours
Interval 4.0 to 10.0
|
8.00 Hours
Interval 4.0 to 24.0
|
10.00 Hours
Interval 8.0 to 10.0
|
|
Phase 1b: Time to Reach Maximum Plasma Concentration (Tmax) of Tepotinib
Day 15 of Cycle 1
|
6.00 Hours
Interval 0.25 to 8.03
|
8.00 Hours
Interval 0.25 to 10.0
|
8.00 Hours
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)Population: The PK analysis included all participants who had received at least 1 dose of Tepotinib and who had provided at least 1 plasma concentration measurement of Tepotinib after the first dose.
The Vz/f was defined as the theoretical volume in which the total amount of required to uniformly distribute to produce the desired plasma concentration. Apparent volume of distribution after oral dose (Vz/F) was influenced by the fraction absorbed. The Vz/f was calculated by dividing the dose with area under the concentration time curve from time zero to infinity multiplied with terminal elimination rate constant Lambda(z). Vz/f=Dose/AUC(0-inf)\* Lambda(z).
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=7 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Apparent Volume of Distribution During the Terminal Phase (Vz/f) of Tepotinib
Day 1
|
NA Liter
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z) , Therefore, Vz/f dependent on Lambda(z) were not determined.
|
NA Liter
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z) , Therefore, Vz/f dependent on Lambda(z) were not determined.
|
NA Liter
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z) , Therefore, Vz/f dependent on Lambda(z) were not determined.
|
|
Phase 1b: Apparent Volume of Distribution During the Terminal Phase (Vz/f) of Tepotinib
Day 15
|
NA Liter
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, Vz/f dependent on Lambda(z) were not determined.
|
NA Liter
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, Vz/f dependent on Lambda(z) were not determined.
|
NA Liter
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, Vz/f dependent on Lambda(z) were not determined.
|
SECONDARY outcome
Timeframe: Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)Population: The PK analysis included all participants who had received at least 1 dose of Tepotinib and who had provided at least 1 plasma concentration measurement of Tepotinib after the first dose.
The CL/f is a measure of the rate at which it was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed. The CL/F from plasma was calculated using the formula: Dose divided by area under the concentration time curve from time zero to infinity (AUC0-inf).
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=7 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Apparent Total Body Clearance From Plasma (CL/f) of Tepotinib
Day 1
|
NA liter per hour (L/h)
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, CL/f dependent on Lambda(z) were not determined.
|
NA liter per hour (L/h)
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, CL/f dependent on Lambda(z) were not determined.
|
NA liter per hour (L/h)
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, CL/f dependent on Lambda(z) were not determined.
|
|
Phase 1b: Apparent Total Body Clearance From Plasma (CL/f) of Tepotinib
Day 15
|
NA liter per hour (L/h)
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, CL/f dependent on Lambda(z) were not determined.
|
NA liter per hour (L/h)
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, CL/f dependent on Lambda(z) were not determined.
|
NA liter per hour (L/h)
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, CL/f dependent on Lambda(z) were not determined.
|
SECONDARY outcome
Timeframe: Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)Population: The PK analysis included all participants who had received at least 1 dose of Tepotinib and who had provided at least 1 plasma concentration measurement of Tepotinib after the first dose.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss/f after oral dose was influenced by the fraction absorbed.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=7 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Apparent Volume of Distribution During the Steady State (Vss/f) of Tepotinib
Day 1
|
NA liter
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z).Therefore, Vss/f dependent on Lambda(z) were not determined.
|
NA liter
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z).Therefore, Vss/f dependent on Lambda(z) were not determined.
|
NA liter
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z).Therefore, Vss/f dependent on Lambda(z) were not determined.
|
|
Phase 1b: Apparent Volume of Distribution During the Steady State (Vss/f) of Tepotinib
Day 15
|
NA liter
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z).Therefore, Vss/f dependent on Lambda(z) were not determined.
|
NA liter
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z).Therefore, Vss/f dependent on Lambda(z) were not determined.
|
NA liter
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z).Therefore, Vss/f dependent on Lambda(z) were not determined.
|
SECONDARY outcome
Timeframe: Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)Population: The PK analysis included all participants who had received at least 1 dose of Tepotinib and who had provided at least 1 plasma concentration measurement of Tepotinib after the first dose.
Lambda(z) was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=7 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Apparent Terminal Elimination Rate Constant Lambda(z) of Tepotinib
Day 1
|
NA 1 per hour
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, Lambda(z) was not determined.
|
NA 1 per hour
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, Lambda(z) was not determined.
|
NA 1 per hour
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, Lambda(z) was not determined.
|
|
Phase 1b: Apparent Terminal Elimination Rate Constant Lambda(z) of Tepotinib
Day 15
|
NA 1 per hour
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, Lambda(z) was not determined.
|
NA 1 per hour
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, Lambda(z) was not determined.
|
NA 1 per hour
Geometric Coefficient of Variation NA
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, Lambda(z) was not determined.
|
SECONDARY outcome
Timeframe: Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)Population: The PK analysis included all participants who had received at least 1 dose of Tepotinib and who had provided at least 1 plasma concentration measurement of Tepotinib after the first dose.
Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=7 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 Participants
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 1b: Apparent Terminal Half-life (t1/2) of Tepotinib
Day 1
|
NA Hours
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, t1/2 dependent on Lambda Z were not determined.
|
NA Hours
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, t1/2 dependent on Lambda Z were not determined.
|
NA Hours
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, t1/2 dependent on Lambda Z were not determined.
|
|
Phase 1b: Apparent Terminal Half-life (t1/2) of Tepotinib
Day 15
|
NA Hours
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, t1/2 dependent on Lambda Z were not determined.
|
NA Hours
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, t1/2 dependent on Lambda Z were not determined.
|
NA Hours
Dosing and sampling scheme in Phase Ib did not allow the reliable estimation of apparent terminal rate constant Lambda(z). Therefore, t1/2 dependent on Lambda Z were not determined.
|
SECONDARY outcome
Timeframe: Up to 6.9 yearsPopulation: The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment. As per planned analysis, data for this outcome was analyzed only for phase 2 based on combined analysis of both FHSI-8 and ECOG.
Time-to-symptomatic progression was defined as time (in months) from first study drug administration to the date of deterioration of symptoms assessed by Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index 8 (FHSI-8) (defined as at least a 4-point increase, i.e., higher score, compared with baseline value), or deterioration to Eastern Cooperative Oncology Group (ECOG) performance score 4, or death. FHSI-8 assesses hepatobiliary cancer symptoms with total score ranges from 0 to 32 (0 = the best quality of life; 32 = the worst quality of life with severe symptoms). ECOG assess participant's performance status on a scale of 0 to 5, where 0=fully active and 5=dead.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=38 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=37 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 2: Time-to-Symptomatic Progression (TTSP)
|
2.2 Months
Interval 1.4 to 4.2
|
2.7 Months
Interval 0.9 to 3.7
|
—
|
SECONDARY outcome
Timeframe: Time from randomization until the first occurrence of PD assessed up to 6.9 yearsPopulation: The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.
The objective response rate (ORR) was defined as the percentage of participants who had achieved complete response (CR) or partial response (PR) as the best overall response according to radiological assessments as adjudicated by the IRC from randomization until the first occurrence of PD. CR: Complete Response (CR) defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=38 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=37 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR) Based on Tumor Assessment by the IRC
|
10.5 Percentage of participants
Interval 4.8 to 21.5
|
0 Percentage of participants
Interval 0.0 to 6.8
|
—
|
SECONDARY outcome
Timeframe: Time from randomization until the first occurrence of PD assessed up to 6.9 yearsPopulation: The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.
Disease control was defined as CR, PR, or stable disease (SD) as the best overall response according to radiological assessments as adjudicated by the IRC from randomization until the first occurrence of PD. CR defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started. Percentage of participants with disease control were reported.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=38 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=37 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 2: Percentage of Participants With Disease Control Based on Tumor Assessment by IRC According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) Criteria
|
50 Percentage of participants
Interval 37.1 to 62.9
|
21.6 Percentage of participants
Interval 12.6 to 34.5
|
—
|
SECONDARY outcome
Timeframe: Time from randomization to disease progression or occurrence of death due to any cause within 84 days of either randomization or the last tumor assessment, assessed up to 6.9 yearsPopulation: The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.
Progression-free survival (assessed by the Investigator) time was defined as the time in months from randomization to either first observation of radiologically confirmed progression disease by the investigator or occurrence of death due to any cause within 84 days of either randomization or the last tumor assessment. PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 mm. PFS was measured using Kaplan-Meier (KM) estimates.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=38 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=37 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 2: Progression-free Survival (PFS) Based on Tumor Assessment by the Investigator
|
3.2 Months
Interval 2.7 to 5.6
|
2.8 Months
Interval 1.5 to 2.8
|
—
|
SECONDARY outcome
Timeframe: Time from randomization until the first occurrence of PD assessed up to 6.9 yearsPopulation: The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.
The objective response rate was defined as the percentage of participants who had achieved CR or PR as the best overall response according to radiological assessments as adjudicated by the investigator from randomization until the first occurrence of PD. CR defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=38 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=37 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR) Based on Tumor Assessment by the Investigator
|
15.8 Percentage of participants
Interval 8.4 to 27.7
|
2.7 Percentage of participants
Interval 0.6 to 11.2
|
—
|
SECONDARY outcome
Timeframe: Approximately up to 6.9 yearsPopulation: The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.
Disease control was defined as CR, PR, or stable disease (SD) as the best overall response according to radiological assessments as adjudicated by the IRC from randomization until the first occurrence of PD. CR defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started. Percentage of participants with disease control were reported.
Outcome measures
| Measure |
Phase 1b: Tepotinib 300 mg
n=38 Participants
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=37 Participants
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|
|
Phase 2: Percentage of Participants With Disease Control Based on Tumor Assessment by Investigator According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) Criteria
|
60.5 Percentage of Participants
Interval 47.2 to 72.4
|
45.9 Percentage of Participants
Interval 33.2 to 59.2
|
—
|
Adverse Events
Phase 1b: Tepotinib 300 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 7 deaths
Phase 1b: Tepotinib 500 mg
Serious events: 9 serious events
Other events: 14 other events
Deaths: 11 deaths
Phase 1b: Tepotinib 1000 mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 3 deaths
Phase 2: Tepotinib
Serious events: 23 serious events
Other events: 43 other events
Deaths: 24 deaths
Phase 2 Sorafenib
Serious events: 12 serious events
Other events: 43 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Phase 1b: Tepotinib 300 mg
n=7 participants at risk
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 participants at risk
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 participants at risk
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 2: Tepotinib
n=45 participants at risk
Participants randomized to receive Tepotinib recommended Phase 2 dose (RP2D) determined from Phase 1b over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 2 Sorafenib
n=44 participants at risk
Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.4%
2/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.5%
2/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.4%
2/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Encapsulating peritoneal sclerosis
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Disease progression
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
15.6%
7/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.5%
2/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Asthenia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Hernia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Oedema peripheral
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.4%
2/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Infections and infestations
Candida infection
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Lipase increased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.4%
2/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.4%
2/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
Other adverse events
| Measure |
Phase 1b: Tepotinib 300 mg
n=7 participants at risk
Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 500 mg
n=14 participants at risk
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 1b: Tepotinib 1000 mg
n=6 participants at risk
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 2: Tepotinib
n=45 participants at risk
Participants randomized to receive Tepotinib recommended Phase 2 dose (RP2D) determined from Phase 1b over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
Phase 2 Sorafenib
n=44 participants at risk
Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
|
|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Oedema
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.7%
3/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Oedema peripheral
|
28.6%
2/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
28.6%
4/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
44.4%
20/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Pain
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
28.6%
4/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
33.3%
2/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
15.6%
7/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
15.9%
7/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.8%
3/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
14.3%
2/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.7%
3/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.8%
3/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Infections and infestations
Infection
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
2/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
50.0%
3/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
15.6%
7/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
20.5%
9/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Amylase increased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
14.3%
2/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
8.9%
4/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
15.9%
7/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
42.9%
3/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
21.4%
3/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
66.7%
4/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
22.2%
10/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
36.4%
16/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
50.0%
3/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
11.1%
5/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.8%
3/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
8.9%
4/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
25.0%
11/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Blood creatinine increased
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
50.0%
3/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
15.6%
7/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Creatinine renal clearance increased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.7%
3/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.7%
3/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
18.2%
8/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Lipase increased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
21.4%
3/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.4%
2/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
18.2%
8/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.4%
2/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
9.1%
4/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Platelet count decreased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
15.6%
7/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
15.9%
7/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.8%
3/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
White blood cell count increased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Investigations
Weight decreased
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.4%
2/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
20.5%
9/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
21.4%
3/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
33.3%
2/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
35.6%
16/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
40.9%
18/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
14.3%
2/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
8.9%
4/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.5%
2/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
11.1%
5/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.5%
2/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.8%
3/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
66.7%
4/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
26.7%
12/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
9.1%
4/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.4%
2/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.8%
3/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.8%
3/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
8.9%
4/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
11.4%
5/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
14.3%
2/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
21.4%
3/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.4%
2/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
11.4%
5/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.8%
3/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.8%
3/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.4%
2/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
9.1%
4/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
33.3%
2/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Reproductive system and breast disorders
Penile swelling
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
25.0%
11/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
11.4%
5/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
24.4%
11/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
61.4%
27/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
21.4%
3/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
33.3%
2/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
8.9%
4/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
9.1%
4/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
14.3%
2/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.8%
3/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
27.3%
12/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
14.3%
2/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
8.9%
4/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.5%
2/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.7%
3/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.5%
2/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Eye disorders
Dry eye
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
57.1%
4/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
28.6%
4/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
20.0%
9/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
11.4%
5/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
2/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
42.9%
6/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
24.4%
11/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
20.5%
9/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
14.3%
2/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.4%
2/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
15.9%
7/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
21.4%
3/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
50.0%
3/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
24.4%
11/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
9.1%
4/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
28.6%
4/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
66.7%
4/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
13.3%
6/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
18.2%
8/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
42.9%
6/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
66.7%
4/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
35.6%
16/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
38.6%
17/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
21.4%
3/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
8.9%
4/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
13.6%
6/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
9.1%
4/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
21.4%
3/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
33.3%
2/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
8.9%
4/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
15.9%
7/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.2%
1/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.8%
3/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
21.4%
3/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.7%
3/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
13.6%
6/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Asthenia
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
11.4%
5/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Chest pain
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.7%
3/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
4.5%
2/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Fatigue
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
21.4%
3/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
33.3%
2/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
26.7%
12/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
29.5%
13/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Disease progression
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
6.7%
3/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
2.3%
1/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Influenza like illness
|
0.00%
0/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Localised oedema
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
16.7%
1/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Malaise
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
7.1%
1/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/14 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/6 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/45 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
0.00%
0/44 • Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks (Phase 1b) and 6.9 years (Phase 2).
The safety analysis set included all participants who had received any dose of the study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER