Trial Outcomes & Findings for Futibatinib in Patients With Specific FGFR Aberrations (NCT NCT04189445)
NCT ID: NCT04189445
Last Updated: 2025-10-08
Results Overview
ORR was defined as the percentage of participants experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on IRC of radiological images. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 millimeters (mm). 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. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
115 participants
Primary outcome timeframe
At the end of every 2 cycles until disease progression (Up to 31 months)
Results posted on
2025-10-08
Participant Flow
Participants took part in the study from 05 August 2020 to 11 November 2024.
A total of 115 participants were enrolled in Cohort A and Cohort B to receive futibatinib; no participants were enrolled in Cohort C.
Participant milestones
| Measure |
Futibatinib (Cohort A)
Participants with advanced or metastatic solid tumors harboring fibroblast growth factor receptor (FGFR)1-4 rearrangements received futibatinib 20 milligrams (mg), oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
Participants with advanced or metastatic solid gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Futibatinib (Cohort C)
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met.
|
|---|---|---|---|
|
Overall Study
STARTED
|
87
|
28
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
87
|
28
|
0
|
Reasons for withdrawal
| Measure |
Futibatinib (Cohort A)
Participants with advanced or metastatic solid tumors harboring fibroblast growth factor receptor (FGFR)1-4 rearrangements received futibatinib 20 milligrams (mg), oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
Participants with advanced or metastatic solid gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Futibatinib (Cohort C)
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met.
|
|---|---|---|---|
|
Overall Study
Withdrawal of consent
|
8
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
25
|
3
|
0
|
|
Overall Study
Death
|
54
|
24
|
0
|
Baseline Characteristics
Futibatinib in Patients With Specific FGFR Aberrations
Baseline characteristics by cohort
| Measure |
Futibatinib (Cohort A)
n=87 Participants
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=28 Participants
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 12.47 • n=99 Participants
|
55.6 years
STANDARD_DEVIATION 13.77 • n=107 Participants
|
58.9 years
STANDARD_DEVIATION 12.87 • n=206 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian/White
|
29 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
36 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
20 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
62 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
22 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At the end of every 2 cycles until disease progression (Up to 31 months)Population: All treated population included all participants who received at least 1 dose of study drug.
ORR was defined as the percentage of participants experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on IRC of radiological images. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 millimeters (mm). 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. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.
Outcome measures
| Measure |
Futibatinib (Cohort A)
n=87 Participants
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=28 Participants
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Futibatinib (Cohort C)
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met.
|
|---|---|---|---|
|
Objective Response Rate (ORR) Based on Independent Central Review (IRC) in Cohorts A and B
|
6.9 percentage of participants
Interval 2.6 to 14.4
|
17.9 percentage of participants
Interval 6.1 to 36.9
|
—
|
PRIMARY outcome
Timeframe: At the end of every 2 cycles until disease progression (Up to 31 months)Population: No participants were enrolled in Cohort C, hence no data was collected.
CR rate was defined as the percentage of participants who achieved a CR (per response criteria for myeloid or lymphoid neoplasm) based on investigator assessment of imaging, peripheral blood, and bone marrow. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of every 2 cycles until disease progression (Up to 31 months)Population: All treated population included all participants who received at least 1 dose of study drug.
ORR was defined as the percentage of participants experiencing a best overall response of PR or CR (per RECIST 1.1), based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 mm. 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. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.
Outcome measures
| Measure |
Futibatinib (Cohort A)
n=87 Participants
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=28 Participants
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Futibatinib (Cohort C)
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met.
|
|---|---|---|---|
|
ORR Based on Investigator Assessment in Cohorts A and B
|
9.2 percentage of participants
Interval 4.1 to 17.3
|
10.7 percentage of participants
Interval 2.3 to 28.2
|
—
|
SECONDARY outcome
Timeframe: At the end of every 2 cycles until disease progression (Up to 31 months)Population: All responders population included all participants who received at least 1 dose of study drug and had a response. No participants were enrolled in Cohort C, hence no data was collected. Overall number of participants analyzed is the number of participants with events.
DOR was defined as the time from the first documentation of response (CR or PR in based on IRC) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 mm. 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. DOR was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Futibatinib (Cohort A)
n=6 Participants
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=5 Participants
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Futibatinib (Cohort C)
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met.
|
|---|---|---|---|
|
Duration of Response (DOR) Based on IRC in Cohorts A, B and C
|
5.6 months
Interval 3.5 to
The upper limit of 95% confidence interval (CI) was not estimable due to insufficient events.
|
3.9 months
Interval 2.1 to
The upper limit of 95% CI was not estimable due to insufficient events.
|
—
|
SECONDARY outcome
Timeframe: At the end of every 2 cycles until disease progression (Up to 31 months)Population: All responders population included all participants who received at least 1 dose of study drug and had a response. No participants were enrolled in Cohort C, hence no data was collected. Overall number of participants analyzed is the number of participants with events.
DOR was defined as the time from the first documentation of response (CR or PR in based on Investigator Assessment) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 mm. 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. DOR was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Futibatinib (Cohort A)
n=8 Participants
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=3 Participants
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Futibatinib (Cohort C)
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met.
|
|---|---|---|---|
|
DOR Based on Investigator Assessment in Cohorts A, B and C
|
5.6 months
Interval 3.0 to
The upper limit of 95% CI was not estimable due to insufficient events.
|
5.6 months
Interval 2.0 to
The upper limit of 95% CI was not estimable due to insufficient events.
|
—
|
SECONDARY outcome
Timeframe: At the end of every 2 cycles until disease progression (Up to 31 months)Population: All treated population included all participants who received at least 1 dose of study drug. Overall number of participants analyzed are the number of participants with reported disease progression or death. No participants were enrolled in Cohort C, hence no data was collected.
PFS was defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on IRC), whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure.
Outcome measures
| Measure |
Futibatinib (Cohort A)
n=71 Participants
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=23 Participants
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Futibatinib (Cohort C)
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met.
|
|---|---|---|---|
|
Progression- Free Survival (PFS) Based on IRC in Cohorts A, B and C
|
1.9 months
Interval 1.8 to 3.5
|
2.9 months
Interval 1.8 to 3.7
|
—
|
SECONDARY outcome
Timeframe: At the end of every 2 cycles until disease progression (Up to 31 months)Population: All treated population included all participants who received at least 1 dose of study drug. Overall number of participants analyzed are the number of participants with reported disease progression or death. No participants were enrolled in Cohort C, hence no data was collected.
PFS was defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on Investigator Review), whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure.
Outcome measures
| Measure |
Futibatinib (Cohort A)
n=71 Participants
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=25 Participants
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Futibatinib (Cohort C)
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met.
|
|---|---|---|---|
|
PFS Based on Investigator Review in Cohorts A, B and C
|
3.3 months
Interval 1.9 to 3.8
|
3.3 months
Interval 2.1 to 3.7
|
—
|
SECONDARY outcome
Timeframe: Up to 31 monthsPopulation: All treated population included all participants who received at least 1 dose of study drug. Overall number of participants analyzed are the number of participants with reported death. No participants were enrolled in Cohort C, hence no data was collected.
OS was defined as the time from the date of first dose to the death date. Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate. The 95% CI for median OS was provided using the Kaplan-Meier procedure.
Outcome measures
| Measure |
Futibatinib (Cohort A)
n=54 Participants
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=24 Participants
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Futibatinib (Cohort C)
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met.
|
|---|---|---|---|
|
Overall Survival (OS) in Cohorts A, B and C
|
11.1 months
Interval 7.3 to 15.6
|
5.9 months
Interval 3.9 to 8.9
|
—
|
SECONDARY outcome
Timeframe: At the end of every 2 cycles until disease progression (Up to 31 months)Population: All treated population included all participants who received at least 1 dose of study drug.
DCR was defined as the percentage of participants experiencing a best overall response of stable disease (SD), PR, or CR (per RECIST 1.1), based on IRC. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of target lesion diameters from the smallest on study (including baseline), with an absolute increase of ≥ 5 mm, or the appearance of new lesions. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 mm. 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. Percentages were rounded off to the nearest single decimal place.
Outcome measures
| Measure |
Futibatinib (Cohort A)
n=87 Participants
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=28 Participants
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Futibatinib (Cohort C)
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met.
|
|---|---|---|---|
|
Disease Control Rate (DCR) Based on IRC in Cohort A and B
|
37.9 percentage of participants
Interval 27.7 to 49.0
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
—
|
SECONDARY outcome
Timeframe: At the end of every 2 cycles until disease progression (Up to 31 months)Population: All treated population included all participants who received at least 1 dose of study drug.
DCR was defined as the percentage of participants experiencing a best overall response of SD, PR, or CR (per RECIST 1.1), based on IRC. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of target lesion diameters from the smallest on study (including baseline), with an absolute increase of ≥ 5 mm, or the appearance of new lesions. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 mm. 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. Percentages were rounded off to the nearest single decimal place.
Outcome measures
| Measure |
Futibatinib (Cohort A)
n=87 Participants
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=28 Participants
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Futibatinib (Cohort C)
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met.
|
|---|---|---|---|
|
DCR Based on Investigator Review in Cohort A and B
|
52.9 percentage of participants
Interval 41.9 to 63.7
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
—
|
SECONDARY outcome
Timeframe: Up to 31 monthsPopulation: No participants were enrolled in Cohort C, hence no data was collected.
CR+CRi rate was defined as the percentage of participants who achieved a CR or CRi.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 31 monthsPopulation: No participants were enrolled in Cohort C, hence no data was collected.
Duration of CR was defined as the time from the first documentation of CR to the first documentation of recurrence or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 31 monthsPopulation: No participants were enrolled in Cohort C, hence no data was collected.
Duration of CR+CRi was defined as the time from the first documentation of CR or CRi to the first documentation of disease relapse or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 31 monthsPopulation: No participants were enrolled in Cohort C, hence no data was collected.
CCyR rate was defined as the percentage of participants who achieved a CCyR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 31 monthsPopulation: No participants were enrolled in Cohort C, hence no data was collected.
PCyR rate was defined as the percentage of participants who achieved a PCyR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 31 monthsPopulation: No participants were enrolled in Cohort C, hence no data was collected.
RFS was defined as the time from first documentation of CR to the date of death (any cause) or disease relapse or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 31 monthsPopulation: No participants were enrolled in Cohort C, hence no data was collected.
EFS was defined as the time from first dose of study therapy to treatment failure, disease relapse after CR, or participant death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the first dose of study drug up to 30 days after the last dose (Up to 31 months)Population: All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug. A treatment-emergent AE (TEAE) is defined as an AE that is starting or worsening at the time of or after the first dose of study drug administration and within 30 days after the last dose of study drug, and does not necessarily have a causal relationship to the use of the study drug.
Outcome measures
| Measure |
Futibatinib (Cohort A)
n=87 Participants
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=28 Participants
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
Futibatinib (Cohort C)
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) - Cohort A, B and C
|
87 Participants
|
27 Participants
|
—
|
Adverse Events
Futibatinib (Cohort A)
Serious events: 23 serious events
Other events: 86 other events
Deaths: 54 deaths
Futibatinib (Cohort B)
Serious events: 6 serious events
Other events: 27 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Futibatinib (Cohort A)
n=87 participants at risk
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=28 participants at risk
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
|---|---|---|
|
Eye disorders
Eyelid ptosis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Ascites
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Subileus
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Asthenia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Fatigue
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
General physical health deterioration
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
COVID-19
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Device related infection
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Escherichia sepsis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Pneumonia
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood lactic acid increased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
General physical condition abnormal
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Renal and urinary disorders
Calculus urinary
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Renal and urinary disorders
Haematuria
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
5/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Vascular disorders
Hypotension
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Hepatobiliary disorders
Haemobilia
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
Other adverse events
| Measure |
Futibatinib (Cohort A)
n=87 participants at risk
Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
|
Futibatinib (Cohort B)
n=28 participants at risk
Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
|
|---|---|---|
|
Cardiac disorders
Cardiac disorder
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Cardiac disorders
Tachycardia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Cardiac disorders
Sinus tachycardia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Blood and lymphatic system disorders
Anaemia
|
18.4%
16/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
10.7%
3/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Cardiac disorders
Sinus bradycardia
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Congenital, familial and genetic disorders
Congenital dyskeratosis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Ear and labyrinth disorders
Deafness
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Ear and labyrinth disorders
Ear pain
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Keratitis
|
4.6%
4/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Dry eye
|
3.4%
3/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Vision blurred
|
3.4%
3/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Cataract
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Lacrimation increased
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Diplopia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Eye discharge
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Eye disorder
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Ocular hyperaemia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Trichiasis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Xerophthalmia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Retinal disorder
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Blepharitis
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Eye pain
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Eye disorders
Serous retinal detachment
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
41.4%
36/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
21.4%
6/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Constipation
|
32.2%
28/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
10.7%
3/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Dry mouth
|
23.0%
20/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.1%
14/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Stomatitis
|
13.8%
12/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Nausea
|
9.2%
8/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
21.4%
6/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Vomiting
|
9.2%
8/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
14.3%
4/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.7%
5/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
3/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
3/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Oral pain
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Anal inflammation
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Angular cheilitis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Ascites
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Glossitis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Lip swelling
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Odynophagia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Fatigue
|
17.2%
15/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
14.3%
4/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Asthenia
|
14.9%
13/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Pyrexia
|
6.9%
6/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Oedema peripheral
|
4.6%
4/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Mucosal inflammation
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Pain
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Chest discomfort
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Effusion
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Gait disturbance
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Malaise
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Peripheral swelling
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Secretion discharge
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Tenderness
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
General disorders
Thirst
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Hepatobiliary disorders
Cholestasis
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Hepatobiliary disorders
Hepatic pain
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Paronychia
|
8.0%
7/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
7/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Conjunctivitis
|
4.6%
4/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
10.7%
3/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
COVID-19
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Gingivitis
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Abscess limb
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Cystitis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Dermatophytosis of nail
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Ear infection
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Onychomycosis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Oral candidiasis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Oral herpes
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Otitis externa
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Pneumonia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Tinea pedis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Tooth infection
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Vaginal infection
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Injury, poisoning and procedural complications
Fall
|
3.4%
3/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Injury, poisoning and procedural complications
Injury
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Injury, poisoning and procedural complications
Neurological procedural complication
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Alanine aminotransferase increased
|
21.8%
19/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
21.4%
6/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Aspartate aminotransferase increased
|
17.2%
15/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
25.0%
7/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood creatinine increased
|
12.6%
11/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
10.7%
3/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.9%
6/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.7%
5/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood alkaline phosphatase increased
|
4.6%
4/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood phosphorus increased
|
4.6%
4/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Lymphocyte count decreased
|
3.4%
3/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Weight decreased
|
3.4%
3/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood albumin abnormal
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood calcium increased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood creatine increased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood fibrinogen increased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood magnesium decreased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood triglycerides increased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood urine present
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Creatinine renal clearance decreased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Electrocardiogram QT prolonged
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Heart rate abnormal
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
International normalised ratio increased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Myoglobin blood increased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Neutrophil count decreased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Platelet count decreased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
SARS-CoV-2 test positive
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
White blood cell count decreased
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
80.5%
70/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
89.3%
25/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.7%
18/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
35.7%
10/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.6%
4/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.6%
4/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
10.7%
3/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.4%
3/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.2%
8/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
7/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
6/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.4%
3/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
3/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Dysgeusia
|
12.6%
11/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Headache
|
5.7%
5/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Paraesthesia
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Ataxia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Encephalopathy
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Neuralgia
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Somnolence
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Nervous system disorders
Syncope
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Psychiatric disorders
Anxiety
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Psychiatric disorders
Depressed mood
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Psychiatric disorders
Disorientation
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
7.1%
2/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Renal and urinary disorders
Dysuria
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Renal and urinary disorders
Renal colic
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.9%
6/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
10.7%
3/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
5/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.5%
10/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
8.0%
7/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
6.9%
6/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.6%
4/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.6%
4/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
4.6%
4/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
3.4%
3/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.3%
2/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Vascular disorders
Hypotension
|
1.1%
1/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
0.00%
0/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
|
Vascular disorders
Embolism
|
0.00%
0/87 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
3.6%
1/28 • From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place