Trial Outcomes & Findings for Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements (NCT NCT04093362)
NCT ID: NCT04093362
Last Updated: 2025-02-07
Results Overview
PFS was defined as the time from date of randomization to the date of documentation of disease progression by independent central review (ICR), or date of death, whichever occurs first. Response assessments were made based on Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
10 participants
Primary outcome timeframe
Up to approximately 28 months
Results posted on
2025-02-07
Participant Flow
A total of 10 participants took part in the study from 06 January 2021 to 22 April 2024.
Total 10 participants with advanced cholangiocarcinoma were enrolled \& randomized to receive either futibatinib or gemcitabine-cisplatin. The study was later terminated by the sponsor due to poor recruitment.
Participant milestones
| Measure |
Futibatinib
Participants received futibatinib at an oral dose of 20 milligrams (mg), administered once daily (QD) in each 21-day cycle up to a maximum of 649 days.
|
Gemcitabine-Cisplatin
Participants received cisplatin 25 milligrams per square meter (mg/m\^2) intravenous (IV) infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle up to a maximum of 155 days.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Futibatinib
Participants received futibatinib at an oral dose of 20 milligrams (mg), administered once daily (QD) in each 21-day cycle up to a maximum of 649 days.
|
Gemcitabine-Cisplatin
Participants received cisplatin 25 milligrams per square meter (mg/m\^2) intravenous (IV) infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle up to a maximum of 155 days.
|
|---|---|---|
|
Overall Study
Study Termination
|
1
|
1
|
|
Overall Study
Withdrawal of Consent
|
1
|
0
|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Reason not Specified
|
1
|
2
|
Baseline Characteristics
Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
Baseline characteristics by cohort
| Measure |
Futibatinib
n=4 Participants
Participants received futibatinib at an oral dose of 20 mg, administered QD in each 21-day cycle up to a maximum of 649 days.
|
Gemcitabine-Cisplatin
n=6 Participants
Participants received cisplatin 25 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle up to a maximum of 155 days.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 9.46 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 12.77 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 12.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 28 monthsPopulation: As pre-specified in protocol, a total of 162 PFS events were required to perform PFS analysis. As only 10 participants were enrolled in this study, hence no data was collected or analyzed as planned for this outcome measure.
PFS was defined as the time from date of randomization to the date of documentation of disease progression by independent central review (ICR), or date of death, whichever occurs first. Response assessments were made based on Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 28 monthsPopulation: The data for this outcome measure was not collected or analyzed as planned because the study was terminated early due to poor recruitment.
ORR was defined as the proportion of participants experiencing a best overall response of partial response (PR) or complete response (CR) as per RECIST 1.1, based on ICR. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to less than (\<)10 millimeters (mm) and disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10-mm short axis)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 28 monthsPopulation: The data for this outcome measure was not collected or analyzed as planned because the study was terminated early due to poor recruitment.
DCR was defined as the proportion of participants experiencing a best overall response of stable disease (SD), PR or CR as per RECIST 1.1, based on central assessment of radiologic images. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 mm and disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10-mm short axis).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 28 monthsPopulation: The data for this outcome measure was not collected or analyzed as planned because the study was terminated early due to poor recruitment.
OS was defined as the time from the date of randomization until the date of death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 28 monthsPopulation: As pre-specified in protocol, a total of 162 PFS events were required to perform PFS analysis. As only 10 participants were enrolled in this study, hence no data was collected for this outcome measure.
PFS per investigator assessment is defined as the time from date of randomization to the date of disease progression based on investigator assessment of radiographic images or death, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 28 monthsPopulation: All Treated Population included all participants who received at least one dose of study drug.
An adverse event (AE) was defined as any untoward medical condition in clinical investigation participant administered drug; it does not necessarily have to have causal relationship with this treatment. A TEAE was defined as an AE that started or worsened at the time of or after first dose of study drug administration and within 30 days after last dose of study drug and does not necessarily have a causal relationship to use of the study drug. TEAEs were assessed by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0). SAE was any untoward medical occurrence that at any dose: results in death, is life-threatening, required in participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, important medical event. TEAEs included any clinically significant changes in clinical laboratory tests, vital signs, ophthalmological exams, and 12-lead electrocardiogram (ECG).
Outcome measures
| Measure |
Futibatinib
n=4 Participants
Participants received futibatinib at an oral dose of 20 mg, administered QD in each 21-day cycle up to a maximum of 649 days.
|
Gemcitabine-Cisplatin
n=5 Participants
Participants received cisplatin 25 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle up to a maximum of 155 days.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
TEAEs
|
4 Participants
|
5 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
SAEs
|
2 Participants
|
3 Participants
|
Adverse Events
Futibatinib
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Gemcitabine-Cisplatin
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Futibatinib
n=4 participants at risk
Participants received futibatinib at an oral dose of 20 mg, administered QD in each 21-day cycle up to a maximum of 649 days.
|
Gemcitabine-Cisplatin
n=5 participants at risk
Participants received cisplatin 25 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle up to a maximum of 155 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Futibatinib
n=4 participants at risk
Participants received futibatinib at an oral dose of 20 mg, administered QD in each 21-day cycle up to a maximum of 649 days.
|
Gemcitabine-Cisplatin
n=5 participants at risk
Participants received cisplatin 25 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle up to a maximum of 155 days.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
60.0%
3/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Paronychia
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Investigations
Blood follicle stimulating hormone decreased
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Investigations
Lipase increased
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
75.0%
3/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
2/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
2/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Eye disorders
Ocular hyperaemia
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Eye disorders
Serous retinopathy
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
100.0%
5/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
60.0%
3/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
General disorders
Face oedema
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
60.0%
3/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
60.0%
3/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrioventricular block second degree
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Adrenal insufficiency
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
25.0%
1/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of study (Up to approximately 28 months)
All Treated Population included all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place