Trial Outcomes & Findings for A Phase Ib/II Study of Fisogatinib(BLU-554) in Subjects With Hepatocellular Carcinoma (NCT NCT04194801)
NCT ID: NCT04194801
Last Updated: 2023-02-06
Results Overview
Number of DLT (Dose-limiting toxicity) During the Administration of BLU-554 in Combination with CS1001. All toxicity or adverse events (AEs) are graded according to NCI-CTCAE 5.0. Any AE occurring during C1 (21 days) that is not clearly caused by something other than investigational drug.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Cycle 1 (21 days) of treatment
Results posted on
2023-02-06
Participant Flow
Participants were screened across 19 centers and enrolled across 11 centers in China. The study consists of 2 parts, including Phase Ib dose escalation and Phase II dose expansion. A total of 26 participants were enrolled in the study and all received ≥ 1 dose of study drug.
Participant milestones
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|
|
Part Ib/II End Of Treatment-BLU554
STARTED
|
4
|
7
|
15
|
|
Part Ib/II End Of Treatment-BLU554
COMPLETED
|
0
|
0
|
0
|
|
Part Ib/II End Of Treatment-BLU554
NOT COMPLETED
|
4
|
7
|
15
|
|
Part Ib/II End Of Treatment-CS1001
STARTED
|
4
|
7
|
15
|
|
Part Ib/II End Of Treatment-CS1001
COMPLETED
|
0
|
0
|
0
|
|
Part Ib/II End Of Treatment-CS1001
NOT COMPLETED
|
4
|
7
|
15
|
|
Part Ib/II End of Study
STARTED
|
4
|
7
|
15
|
|
Part Ib/II End of Study
COMPLETED
|
0
|
0
|
0
|
|
Part Ib/II End of Study
NOT COMPLETED
|
4
|
7
|
15
|
Reasons for withdrawal
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|
|
Part Ib/II End Of Treatment-BLU554
Adverse Event
|
0
|
2
|
1
|
|
Part Ib/II End Of Treatment-BLU554
Death
|
0
|
0
|
1
|
|
Part Ib/II End Of Treatment-BLU554
Physician Decision
|
1
|
0
|
0
|
|
Part Ib/II End Of Treatment-BLU554
Radiographic disease progression
|
3
|
4
|
9
|
|
Part Ib/II End Of Treatment-BLU554
Symptomatic deterioration without radiographic evidence
|
0
|
1
|
0
|
|
Part Ib/II End Of Treatment-BLU554
Other
|
0
|
0
|
2
|
|
Part Ib/II End Of Treatment-BLU554
Ongoing treatment
|
0
|
0
|
2
|
|
Part Ib/II End Of Treatment-CS1001
Adverse Event
|
1
|
0
|
2
|
|
Part Ib/II End Of Treatment-CS1001
Death
|
0
|
0
|
1
|
|
Part Ib/II End Of Treatment-CS1001
Radiographic disease progression
|
3
|
6
|
9
|
|
Part Ib/II End Of Treatment-CS1001
Symptomatic deterioration without radiographic evidence
|
0
|
1
|
0
|
|
Part Ib/II End Of Treatment-CS1001
Other
|
0
|
0
|
1
|
|
Part Ib/II End Of Treatment-CS1001
Ongoing treatment
|
0
|
0
|
2
|
|
Part Ib/II End of Study
Death
|
2
|
3
|
3
|
|
Part Ib/II End of Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Part Ib/II End of Study
Withdrawal by Subject
|
1
|
0
|
2
|
|
Part Ib/II End of Study
Study ended by sponsor
|
1
|
3
|
8
|
|
Part Ib/II End of Study
Ongoing treatment
|
0
|
0
|
2
|
Baseline Characteristics
A Phase Ib/II Study of Fisogatinib(BLU-554) in Subjects With Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=7 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=15 Participants
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Total
n=26 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
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Continuous
|
43.5 Years
STANDARD_DEVIATION 4.80 • n=5 Participants
|
48.4 Years
STANDARD_DEVIATION 11.82 • n=7 Participants
|
51.6 Years
STANDARD_DEVIATION 12.37 • n=5 Participants
|
49.5 Years
STANDARD_DEVIATION 11.43 • n=4 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
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days) of treatmentPopulation: Fisogatinib (BLU-554) 600mg arm, 7 subjects were enrolled, of whom 6 completed DLT evaluation and 1 was unevaluable
Number of DLT (Dose-limiting toxicity) During the Administration of BLU-554 in Combination with CS1001. All toxicity or adverse events (AEs) are graded according to NCI-CTCAE 5.0. Any AE occurring during C1 (21 days) that is not clearly caused by something other than investigational drug.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=6 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Phase Ib: Patients With Event(s) of Dose-limiting Toxicity
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Safety and tolerance assessments continued for the duration of treatment. AEs and SAEs will be collected from time of signature of main informed consent, throughout the treatment period and including the follow-up period, up to approximate 22 months.Population: Baseline Analysis Population consists of all participants receiving at least one dose of investigational product
An AE was any untoward medical occurrence after clinical study subjects receive study drug. An SAE was any event that meets any the following criteria: death, life-threatening; inpatient hospitalization or prolongation, persistent or significant disability/incapacity;congenital malformation/birth defects and significant medical events. AE and SAE were graded by CTCAE version 5.0 by severity, from Grade 1 mild to Grade 5 death related AE.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=7 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Phase Ib: Safety and Tolerance
Treatment-Emergent Adverse Event（TEAE）
|
4 Participants
|
7 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
TEAE at least one related to CS1001 or BLU-554
|
4 Participants
|
6 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
Grade 3-5 TEAE
|
2 Participants
|
6 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
Grade 3-5 TEAE at least one related to CS1001 or BLU-554
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
Serious TEAE
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
Serious TEAE at least one related to CS1001 or BLU-554
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
Immune-related TEAE
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
Infusion-related reaction TEAE
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
TEAE Leading to CS1001 rate of infusion modification
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
TEAE Leading to CS1001 dose interruption
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
TEAE Leading to CS1001 permanently discontinuation
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
TEAE Leading to BLU-554 dose reduction
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
TEAE Leading to BLU-554 dose interruption
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
TEAE Leading to BLU-554 permanently discontinuation
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Phase Ib: Safety and Tolerance
TEAE Leading to death
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Imaging (CT or MRI) assessments per RECIST v1.1 will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months.Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1 .1) for target lesions and assessed by MRI/ CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \> =30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of subjects who achieve objective tumor response (CR or PR) will be summarized.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=15 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Phase II: Objective Response Rate (ORR) Assessed by Investigator Based on RECIST Version 1.1
Responder
|
3 Participants
|
—
|
—
|
—
|
|
Phase II: Objective Response Rate (ORR) Assessed by Investigator Based on RECIST Version 1.1
Non-Responder
|
12 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Imaging (CT or MRI) assessments per RECIST v1.1 will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months.Disease control rate (DCR) is defined as the proportion of participants who achieve complete response (CR), partial response (PR), and stable disease (SD) based on Response Evaluation Criteria In Solid Tumors (RECIST)v1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1 .1) for target lesions and assessed by MRI/ CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \> =30% decrease in the sum of the longest diameter of target lesions. Stable disease(SD) is defined as a tumor that does not meet the criteria for progression or for response.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=7 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=15 Participants
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Disease Control Rate Assessed by Investigator
|
1 Participants
|
3 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Imaging (CT or MRI) assessments per RECIST v1.1 will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months.Population: Only include participants with confirmed response (CR or PR).
Duration of response for responders (CR or PR) is defined as the time interval between the date of the earliest qualifying response and the date of PD or death for any cause (whichever occurs earlier). For subjects who are alive without progression following the qualifying response, duration of response will be censored on the date of last evaluable tumor assessment or last follow-up for progression of disease.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=1 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=3 Participants
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Duration of Response Assessed by Investigator
|
—
|
4.34 Months
The upper bound and lower bound of the confidence interval could not be calculated
|
NA Months
1. The median of DOR is not reached
2. The upper bound and lower bound of the confidence interval could not be calculated
|
—
|
SECONDARY outcome
Timeframe: Imaging (CT or MRI) assessments per RECIST v1.1 will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months.Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1 .1) for target lesions and assessed by MRI/ CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \> =30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of subjects who achieve objective tumor response (CR or PR) will be summarized.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=7 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Phase Ib: Objective Response Rate (ORR) Assessed by Investigator Based on RECIST Version 1.1
Responder
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Phase Ib: Objective Response Rate (ORR) Assessed by Investigator Based on RECIST Version 1.1
Non-Responder
|
4 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose of Cycle 1, 2, 4, 5, 7, 10, 13, 16 and every 8 cycles thereafter. Up to 22 months.Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=7 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=15 Participants
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Patients With Anti-CS1001 Antibody
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Subject should be followed from time of registration till the time of subject death. Up to 22 months.Overall survival is defined as the time interval between the date of the first investigational product dose to the date of death from any cause
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=7 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=15 Participants
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Overall Survival
|
16.2 Months
Interval 8.6 to
The upper bound of the confidence interval could not be estimated because of insufficient number of events.
|
NA Months
Interval 0.6 to
1. The median could not be estimated because of insufficient number of events.
2. The upper bound of the confidence interval could not be estimated because of insufficient number of events.
|
NA Months
Interval 7.1 to
1. The median could not be estimated because of insufficient number of events.
2. The upper bound of the confidence interval could not be estimated because of insufficient number of events.
|
—
|
SECONDARY outcome
Timeframe: Imaging (CT or MRI) assessments by FGF19 protein and PD-L1 protein level will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months.Population: Efficacy analysis dataset with dichotomous PD-L1 parameters at baseline.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=3 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=12 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=14 Participants
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
n=1 Participants
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Disease Control Rate by PD-L1 Protein Level
|
2 Participants
|
7 Participants
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Imaging (CT or MRI) assessments by FGF19 protein and PD-L1 protein level will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months.Population: Efficacy analysis dataset with dichotomous PD-L1 parameters at baseline.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=3 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=12 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=14 Participants
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
n=1 Participants
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR) by PD-L1 Protein Level
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Imaging (CT or MRI) assessments per RECIST v1.1 will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months.Progression-free Survival is defined as the time from the date of first study dose to disease progression or death (whichever occurs first).
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=7 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=15 Participants
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Progression-free Survival Assessed by Investigator
|
2.3 Months
Interval 2.1 to
The upper bound of the confidence interval could not be estimated because of insufficient number of events.
|
2.1 Months
Interval 0.6 to 4.1
|
4.1 Months
Interval 1.4 to 6.2
|
—
|
SECONDARY outcome
Timeframe: Imaging (CT or MRI) assessments per RECIST v1.1 will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months.Time to Progression is defined as the time from the date of first study dose to disease progression. Subjects without event (no disease progression) will be censored at the date of "last tumor assessment".
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=7 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=15 Participants
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Time to Progression Assessed by Investigator
|
2.3 Months
Interval 2.1 to
The upper bound of the confidence interval could not be estimated because of insufficient number of events.
|
3.1 Months
Interval 1.1 to
The upper bound of the confidence interval could not be estimated because of insufficient number of events.
|
4.2 Months
Interval 1.4 to 6.2
|
—
|
SECONDARY outcome
Timeframe: Safety and tolerance assessments continued for the duration of treatment. AEs and SAEs will be collected from time of signature of main informed consent, throughout the treatment period and including the follow-up period, up to approximate 22 months.Population: Baseline Analysis Population consists of all participants receiving at least one dose of investigational product
An AE was any untoward medical occurrence after clinical study subjects receive study drug. An SAE was any event that meets any the following criteria: death, life-threatening; inpatient hospitalization or prolongation, persistent or significant disability/incapacity;congenital malformation/birth defects and significant medical events. AE and SAE were graded by CTCAE version 5.0 by severity, from Grade 1 mild to Grade 5 death related AE.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=15 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Phase II: Safety and Tolerance
Treatment-Emergent Adverse Event（TEAE）
|
15 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
TEAE at least one related to CS1001 or BLU-554
|
15 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
Grade 3-5 TEAE
|
7 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
Grade 3-5 TEAE at least one related to CS1001 or BLU-554
|
6 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
Serious TEAE
|
5 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
Serious TEAE at least one related to CS1001 or BLU-554
|
3 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
Immune-related TEAE
|
4 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
Infusion-related reaction TEAE
|
1 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
TEAE Leading to CS1001 rate of infusion modification
|
0 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
TEAE Leading to CS1001 dose interruption
|
6 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
TEAE Leading to CS1001 permanently discontinuation
|
2 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
TEAE Leading to BLU-554 dose reduction
|
8 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
TEAE Leading to BLU-554 dose interruption
|
4 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
TEAE Leading to BLU-554 permanently discontinuation
|
1 Participants
|
—
|
—
|
—
|
|
Phase II: Safety and Tolerance
TEAE Leading to death
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For BLU554, Cycle 1 day 1( 0, 0.5 to 24 hour post dose) and Cycle 2 day 1( 0, 0.5 to 24 hour post dose).Pharmacokinetic(PK) parameters of accumulation ratio of Fisogatinib (BLU-554),Rac,AUC. Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=5 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Accumulation Ratio of Fisogatinib (BLU-554)
|
1.22 ratio
Geometric Coefficient of Variation 36.41
|
1.35 ratio
Geometric Coefficient of Variation 42
|
—
|
—
|
SECONDARY outcome
Timeframe: For BLU554, Cycle 1 day 1( 0, 0.5 to 24 hour post dose) and Cycle 2 day 1( 0, 0.5 to 24 hour post dose).Pharmacokinetic parameters of area under the serum concentration-time curve (AUC0-τ,ss, Time from 0 to 24h) of Fisogatinib (BLU-554). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=11 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Area Under the Serum Concentration-time Curve (AUC) of Fisogatinib (BLU-554)
|
55.3 h*μg/mL
Geometric Coefficient of Variation 65.43
|
73.8 h*μg/mL
Geometric Coefficient of Variation 29.96
|
—
|
—
|
SECONDARY outcome
Timeframe: For BLU554, Cycle 1 day 1( 0, 0.5 to 24 hour post dose) and Cycle 2 day 1( 0, 0.5 to 24 hour post dose).Pharmacokinetic Parameters of Clearance at Steady State (Clss) of Fisogatinib (BLU-554). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=11 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Clearance at Steady State (CLss) of Fisogatinib (BLU-554)
|
7.24 L/h
Geometric Coefficient of Variation 65.43
|
8.13 L/h
Geometric Coefficient of Variation 29.96
|
—
|
—
|
SECONDARY outcome
Timeframe: For BLU554, Cycle 1 day 1( 0, 0.5 to 24 hour post dose) and Cycle 2 day 1( 0, 0.5 to 24 hour post dose).PK Parameters of Cmax of Fisogatinib (BLU-554). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=15 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Maximum Serum Concentration (Cmax) of Fisogatinib (BLU-554)
|
7.26 μg/mL
Geometric Coefficient of Variation 50.01
|
8.14 μg/mL
Geometric Coefficient of Variation 27.52
|
—
|
—
|
SECONDARY outcome
Timeframe: For BLU554, Cycle 1 day 1( 0, 0.5 to 24 hour post dose) and Cycle 2 day 1( 0, 0.5 to 24 hour post dose).PK Parameters of Tmax of Fisogatinib (BLU-554). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=15 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Time to Maximum Serum Concentration (Tmax) of Fisogatinib (BLU-554)
|
1.53 hour
Interval 0.97 to 3.78
|
2.05 hour
Interval 0.0 to 3.87
|
—
|
—
|
SECONDARY outcome
Timeframe: For CS1001: Cycle 1 day 1(0, 0.5 to 504 hour post dose) and Cycle 4 day 1 (0, 0.5 to 504 hour post dose).PK Parameters of Rac, AUC of Sugemalimab (CS1001). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=3 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=2 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Accumulation Ratio of Sugemalimab (CS1001)
|
1.1 ratio
Geometric Coefficient of Variation 67.01
|
2.44 ratio
Geometric Coefficient of Variation 5.85
|
—
|
—
|
SECONDARY outcome
Timeframe: For CS1001: Cycle 1 day 1(0, 0.5 to 504 hour post dose) and Cycle 4 day 1 (0, 0.5 to 504 hour post dose).PK Parameters of (AUC 0-τ,ss ) of Sugemalimab (CS1001). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=1 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=8 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Area Under the Serum Concentration-time Curve (AUC ) of Sugemalimab (CS1001)
|
148000 h*μg/mL
Geometric Coefficient of Variation NA
There is only one person. So, it did not be calculated.
|
136000 h*μg/mL
Geometric Coefficient of Variation 34.14
|
—
|
—
|
SECONDARY outcome
Timeframe: For CS1001: Cycle 1 day 1(0, 0.5 to 504 hour post dose) and Cycle 4 day 1 (0, 0.5 to 504 hour post dose).PK Parameters of CLss of Sugemalimab (CS1001). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=1 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=6 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Clearance at Steady State (CLss) of Sugemalimab (CS1001)
|
0.00808 L/h
Geometric Coefficient of Variation NA
There is only one person. So, it did not be calculated.
|
0.00821 L/h
Geometric Coefficient of Variation 23.74
|
—
|
—
|
SECONDARY outcome
Timeframe: For CS1001: Cycle 1 day 1(0, 0.5 to 504 hour post dose) and Cycle 4 day 1 (0, 0.5 to 504 hour post dose).PK Parameters of Cmax of Sugemalimab (CS1001). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=3 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=9 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Maximum Serum Concentration (Cmax) of Sugemalimab (CS1001)
|
513 μg/mL
Geometric Coefficient of Variation 11.08
|
463 μg/mL
Geometric Coefficient of Variation 26.16
|
—
|
—
|
SECONDARY outcome
Timeframe: For CS1001: Cycle 1 day 1(0, 0.5 to 504 hour post dose) and Cycle 4 day 1 (0, 0.5 to 504 hour post dose).PK Parameters of Tmax of Sugemalimab (CS1001). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage.
Outcome measures
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=3 Participants
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=9 Participants
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage >=1 Percentage
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Time to Maximum Serum Concentration (Tmax) of Sugemalimab (CS1001)
|
2.02 hour
Interval 2.0 to 7.3
|
2.12 hour
Interval 1.48 to 7.3
|
—
|
—
|
Adverse Events
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 3 deaths
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
Serious events: 5 serious events
Other events: 15 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 participants at risk
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=7 participants at risk
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=15 participants at risk
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
General disorders
Death
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
13.3%
2/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
Other adverse events
| Measure |
Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg
n=4 participants at risk
Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.
|
Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=7 participants at risk
Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg
n=15 participants at risk
Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.
|
|---|---|---|---|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
33.3%
5/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Blood and lymphatic system disorders
Leukaemoid reaction
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Cardiac disorders
Sinus bradycardia
|
50.0%
2/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Cardiac disorders
Wandering pacemaker
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
13.3%
2/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
20.0%
3/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
28.6%
2/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
3/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
57.1%
4/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
80.0%
12/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
57.1%
4/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
13.3%
2/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
57.1%
4/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
20.0%
3/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
General disorders
Asthenia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
General disorders
Malaise
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
28.6%
2/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
40.0%
6/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Infections and infestations
Measles
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Alanine aminotransferase decreased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
4/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
42.9%
3/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
73.3%
11/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Antinuclear antibody increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Antithrombin III decreased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Antithrombin III increased
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
4/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
57.1%
4/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
66.7%
10/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Bilirubin conjugated increased
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
42.9%
3/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
46.7%
7/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Bilirubin urine present
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
28.6%
2/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood albumin increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
28.6%
2/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
46.7%
7/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood bilirubin increased
|
50.0%
2/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
85.7%
6/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
80.0%
12/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood bilirubin unconjugated increased
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
13.3%
2/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood cholesterol decreased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
13.3%
2/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
28.6%
2/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood glucose increased
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
13.3%
2/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood iron increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood magnesium increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Fibrin degradation products increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
33.3%
5/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Glycocholic acid increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
28.6%
2/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
26.7%
4/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
13.3%
2/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Platelet count decreased
|
50.0%
2/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
40.0%
6/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Protein urine present
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
28.6%
2/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
20.0%
3/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
28.6%
2/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Red blood cell sedimentation rate decreased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Total bile acids increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
28.6%
2/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Tri-iodothyronine free increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Tri-iodothyronine increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
13.3%
2/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Weight decreased
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
20.0%
3/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
Weight increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
13.3%
2/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
White blood cell count decreased
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
20.0%
3/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Metabolism and nutrition disorders
Copper deficiency
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
28.6%
2/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
20.0%
3/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
28.6%
2/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
46.7%
7/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
28.6%
2/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
6.7%
1/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
14.3%
1/7 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
0.00%
0/15 • For each participant, adverse event data were collected starting at the time of the first dose of study drug, throughout the treatment period and including the safety follow-up period. Up to 22 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60