Trial Outcomes & Findings for Study Efficacy and Safety of INC280 in Patients With Advanced Hepatocellular Carcinoma. (NCT NCT01737827)
NCT ID: NCT01737827
Last Updated: 2024-09-24
Results Overview
TTP is defined as the time from the date of treatment start to the date of the first documented radiological confirmation of disease progression or death due to underlying cancer. Tumor response was based on investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. For RECIST v1.1, Progressive disease (PD) = At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. If a patient had not had the event at the date of analysis cut-off or when he/she received any further anti-neoplastic therapy, TTP was censored at the time of the last adequate assessment. TTP was estimated using the Kaplan-Meier method.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Up to approximately 8 years and 2 months
Results posted on
2024-09-24
Participant Flow
Participants took part in 9 investigative sites in 4 countries.
Evidence of c-MET pathway dysregulation had to be available to be eligible to participate in this study. After the molecular pre-screening, screening assessments had to be done within 14 days prior to the first dose of INC280. The study included a Dose-Determining Part designed to identify an appropriate dose for patients with hepatocellular carcinoma (HCC) and a Dose Expansion part designed to estimate the efficacy in patients with HCC with different levels of c-MET expression.
Participant milestones
| Measure |
CINC280 300 mg BID Capsule
INC280 300 mg orally twice daily (BID) as capsule
|
CINC280 600 mg BID Capsule
INC280 600 mg orally twice daily (BID) as capsule
|
CINC280 400 mg BID Tablet
INC280 400 mg orally twice daily (BID) as tablet
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
28
|
2
|
|
Overall Study
Dose-Determining Part
|
8
|
0
|
0
|
|
Overall Study
Dose Expansion Part: c-MET High
|
0
|
8
|
2
|
|
Overall Study
Dose Expansion Part: c-MET Low
|
0
|
20
|
0
|
|
Overall Study
Safety Set
|
9
|
27
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
28
|
2
|
Reasons for withdrawal
| Measure |
CINC280 300 mg BID Capsule
INC280 300 mg orally twice daily (BID) as capsule
|
CINC280 600 mg BID Capsule
INC280 600 mg orally twice daily (BID) as capsule
|
CINC280 400 mg BID Tablet
INC280 400 mg orally twice daily (BID) as tablet
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
6
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
|
Overall Study
Progressive Disease
|
5
|
16
|
2
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
1
|
0
|
|
Overall Study
Subject/Guardian Decision
|
0
|
2
|
0
|
Baseline Characteristics
Study Efficacy and Safety of INC280 in Patients With Advanced Hepatocellular Carcinoma.
Baseline characteristics by cohort
| Measure |
CINC280 300 mg BID Capsule
n=8 Participants
INC280 300 mg orally twice daily (BID) as capsule
|
CINC280 600 mg BID Capsule
n=28 Participants
INC280 600 mg orally twice daily (BID) as capsule
|
CINC280 400 mg BID Tablet
n=2 Participants
INC280 400 mg orally twice daily (BID) as tablet
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 9.34 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 0.71 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 8.81 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
c-MET (MET proto-oncogene) status
c-MET High
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
c-MET (MET proto-oncogene) status
c-MET Low
|
6 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 8 years and 2 monthsPopulation: All patients who received at least one dose of INC280. Patients were analyzed according to the treatment group defined in the study protocol to which they were assigned at baseline: Dose-Determining part and Dose Expansion part. In alignment with the primary objective of the study, efficacy was analyzed in the dose expansion part based on the level of c-MET expression, independently of the formulation received, the capsule or the tablet that was introduced later to facilitate the dosing.
TTP is defined as the time from the date of treatment start to the date of the first documented radiological confirmation of disease progression or death due to underlying cancer. Tumor response was based on investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. For RECIST v1.1, Progressive disease (PD) = At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. If a patient had not had the event at the date of analysis cut-off or when he/she received any further anti-neoplastic therapy, TTP was censored at the time of the last adequate assessment. TTP was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Dose Determining
n=8 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
n=10 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
n=20 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
n=30 Participants
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Time to Progression (TTP) by Investigator Assessment Per RECIST v1.1
|
NA months
Not estimable due to insufficient number of participants with events
|
3.6 months
Interval 2.0 to 7.7
|
2.1 months
Interval 1.9 to 2.2
|
2.2 months
Interval 2.0 to 3.2
|
SECONDARY outcome
Timeframe: Up to approximately 8 years and 2 monthsPopulation: All patients who received at least one dose of INC280. Patients were analyzed according to the treatment group defined in the protocol to which they were assigned at baseline: Dose-Determining part and Dose Expansion part. In alignment with the secondary efficacy objective of the study, efficacy was analyzed in the dose expansion part based on the level of c-MET expression, independently of the formulation received, the capsule or the tablet that was introduced later to facilitate the dosing.
Tumor response was based on local investigator assessment per RECIST v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response (BOR) of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Dose Determining
n=8 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
n=10 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
n=20 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
n=30 Participants
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) by Investigator Assessment Per RECIST 1.1
|
0 Percentage of participants
Interval 0.0 to 36.9
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
0 Percentage of participants
Interval 0.0 to 16.8
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
SECONDARY outcome
Timeframe: Up to approximately 8 years and 2 monthsPopulation: All patients who received at least one dose of INC280. Patients were analyzed according to the treatment group defined in the protocol to which they were assigned at baseline: Dose-Determining part and Dose Expansion part. In alignment with the secondary efficacy objective of the study, efficacy was analyzed in the dose expansion part based on the level of c-MET expression, independently of the formulation received, the capsule or the tablet that was introduced later to facilitate the dosing.
Tumor response was based on local investigator assessment per RECIST v1.1. DCR is defined as the percentage of participants with a BOR of Complete Response (CR), Partial Response (PR) and Stable Disease (SD). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression).
Outcome measures
| Measure |
Dose Determining
n=8 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
n=10 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
n=20 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
n=30 Participants
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Disease Control Rate (DCR) by Investigator Assessment Per RECIST 1.1
|
25.0 Percentage of participants
Interval 3.2 to 65.1
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
33.3 Percentage of participants
Interval 17.3 to 52.8
|
SECONDARY outcome
Timeframe: Up to approximately 8 years and 2 monthsPopulation: All patients who received at least one dose of INC280. Patients were analyzed according to the treatment group defined in the protocol to which they were assigned at baseline: Dose-Determining part and Dose Expansion part. In alignment with the secondary efficacy objective of the study, efficacy was analyzed in the dose expansion part based on the level of c-MET expression, independently of the formulation received, the capsule or the tablet that was introduced later to facilitate the dosing.
PFS is defined as the time from date of first study treatment intake to the date of the first radiologically documented progression or death due to any cause or initiation of new antineoplastic therapy. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was analyzed using Kaplan-Meier estimates.
Outcome measures
| Measure |
Dose Determining
n=8 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
n=10 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
n=20 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
n=30 Participants
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Progression-Free Survival (PFS) by Investigator Assessment Per RECIST 1.1
|
NA months
Not estimable due to insufficient number of participants with events
|
3.6 months
Interval 1.2 to
Not estimable due to insufficient number of participants with events
|
2.1 months
Interval 0.9 to 3.2
|
2.2 months
Interval 1.6 to 4.9
|
SECONDARY outcome
Timeframe: Up to approximately 8 years and 2 monthsPopulation: All patients who received at least one dose of INC280. Patients were analyzed according to the treatment group defined in the protocol to which they were assigned at baseline: Dose-Determining part and Dose Expansion part. In alignment with the secondary efficacy objective of the study, efficacy was analyzed in the dose expansion part based on the level of c-MET expression, independently of the formulation received, the capsule or the tablet that was introduced later to facilitate the dosing.
OS is defined as the time from date of first study treatment intake to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact. OS was analyzed using the Kaplan-Meier method.
Outcome measures
| Measure |
Dose Determining
n=8 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
n=10 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
n=20 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
n=30 Participants
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
NA months
Not estimable due to insufficient number of participants with events
|
6.3 months
Interval 2.1 to
Not estimable due to insufficient number of participants with events
|
5.8 months
Interval 3.1 to 8.1
|
5.8 months
Interval 3.2 to 8.1
|
SECONDARY outcome
Timeframe: From first dose of study drug to 30 days after last dose, up to approximately 8 years and 2 monthsPopulation: Safety Set: All patients who received at least one dose of INC280. Patients were analyzed according to the treatment they actually received.
Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.
Outcome measures
| Measure |
Dose Determining
n=9 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
n=27 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
n=2 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
9 Participants
|
27 Participants
|
2 Participants
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related AEs
|
7 Participants
|
17 Participants
|
1 Participants
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
6 Participants
|
13 Participants
|
1 Participants
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related SAEs
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Fatal SAEs
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to last dose, up to approximately 8 years and 1 monthPopulation: Safety Set: All patients who received at least one dose of INC280. Patients were analyzed according to the treatment they actually received.
For patients who did not tolerate the protocol-specified dosing scheme, dose adjustments and interruptions were permitted. Number of participants with dose reductions and dose interruptions of CINC280 is reported in this table.
Outcome measures
| Measure |
Dose Determining
n=9 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
n=27 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
n=2 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Number of Participants With Dose Reductions and Dose Interruptions of CINC280
At least one dose reduction and/or interruption
|
6 Participants
|
18 Participants
|
1 Participants
|
—
|
|
Number of Participants With Dose Reductions and Dose Interruptions of CINC280
At least one dose reduction
|
1 Participants
|
9 Participants
|
1 Participants
|
—
|
|
Number of Participants With Dose Reductions and Dose Interruptions of CINC280
At least one dose interruption
|
6 Participants
|
17 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to last dose, up to approximately 8 years and 1 monthPopulation: Safety Set: All patients who received at least one dose of INC280. Patients were analyzed according to the treatment they actually received.
Dose intensity of INC280 was calculated as actual cumulative dose in milligrams divided by duration of exposure in days.
Outcome measures
| Measure |
Dose Determining
n=9 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
n=27 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
n=2 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Dose Intensity of INC280
|
600.0 mg/day
Interval 450.0 to 957.0
|
1200.0 mg/day
Interval 721.0 to 1200.0
|
674.2 mg/day
Interval 548.0 to 800.0
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 30 minutes and 1, 2, 4, 6 and 8 hours after morning dose and 12 hours after evening dose on Cycle 1 Day 1 and Cycle 1 Day 15. The duration of one cycle was 21 days.Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure. PAS consists of all patients who provided an evaluable PK profile. A profile is considered evaluable if all the following conditions are satisfied: patient received at least one dose of the planned treatments, patient provided at least one primary PK parameter and patient did not vomit within 4 hours after the dosing of INC280. Full PK blood samples were not collected in the Dose-Expansion Part
Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.
Outcome measures
| Measure |
Dose Determining
n=8 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of INC280 in the Dose-Determining Part
Cycle 1 Day 1
|
2140 ng/mL
Geometric Coefficient of Variation 105.4
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of INC280 in the Dose-Determining Part
Cycle 1 Day 15
|
2530 ng/mL
Geometric Coefficient of Variation 86.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 30 minutes and 1, 2, 4, 6 and 8 hours after morning dose and 12 hours after evening dose on Cycle 1 Day 1 and Cycle 1 Day 15. The duration of one cycle was 21 days.Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure. PAS consists of all patients who provided an evaluable PK profile. A profile is considered evaluable if all the following conditions are satisfied: patient received at least one dose of the planned treatments, patient provided at least one primary PK parameter and patient did not vomit within 4 hours after the dosing of INC280. Full PK blood samples were not collected in the Dose-Expansion Part
PK parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.
Outcome measures
| Measure |
Dose Determining
n=8 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of INC280 in the Dose-Determining Part
Cycle 1 Day 1
|
2 hours
Interval 0.5 to 4.0
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of INC280 in the Dose-Determining Part
Cycle 1 Day 15
|
2 hours
Interval 1.0 to 2.03
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 30 minutes and 1, 2, 4, 6 and 8 hours after morning dose and 12 hours after evening dose on Cycle 1 Day 1 and Cycle 1 Day 15. The duration of one cycle was 21 days.Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure. PAS consists of all patients who provided an evaluable PK profile. A profile is considered evaluable if all the following conditions are satisfied: patient received at least one dose of the planned treatments, patient provided at least one primary PK parameter and patient did not vomit within 4 hours after the dosing of INC280. Full PK blood samples were not collected in the Dose-Expansion Part
PK parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12h calculation. A dosing interval was 12 hours for twice daily dosing.
Outcome measures
| Measure |
Dose Determining
n=7 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC0-12h) of INC280 in the Dose-Determining Part
Cycle 1 Day 1
|
7740 hr*ng/mL
Geometric Coefficient of Variation 72.2
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC0-12h) of INC280 in the Dose-Determining Part
Cycle 1 Day 15
|
12300 hr*ng/mL
Geometric Coefficient of Variation 84.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 30 minutes and 1, 2, 4, 6 and 8 hours after morning dose and 12 hours after evening dose on Cycle 1 Day 1 and Cycle 1 Day 15. The duration of one cycle was 21 days.Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure. PAS consists of all patients who provided an evaluable PK profile. A profile is considered evaluable if all the following conditions are satisfied: patient received at least one dose of the planned treatments, patient provided at least one primary PK parameter and patient did not vomit within 4 hours after the dosing of INC280. Full PK blood samples were not collected in the Dose-Expansion Part
PK parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods. Apparent drug clearance from the plasma was calculated as dose/AUCinf.
Outcome measures
| Measure |
Dose Determining
n=7 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Apparent Plasma Clearance (CL/F) of INC280 in the Dose-Determining Part
Cycle 1 Day 1
|
46000 mL/hr
Standard Deviation 38100
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 30 minutes and 1, 2, 4, 6 and 8 hours after morning dose and 12 hours after evening dose on Cycle 1 Day 1 and Cycle 1 Day 15. The duration of one cycle was 21 days.Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure. PAS consists of all patients who provided an evaluable PK profile. A profile is considered evaluable if all the following conditions are satisfied: patient received at least one dose of the planned treatments, patient provided at least one primary PK parameter and patient did not vomit within 4 hours after the dosing of INC280. Full PK blood samples were not collected in the Dose-Expansion Part
PK parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as natural logarithm (ln) 2/terminal elimination rate constant.
Outcome measures
| Measure |
Dose Determining
n=7 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Terminal Elimination Half-life (T1/2) of INC280 in the Dose-Determining Part
Cycle 1 Day 1
|
2.27 hours
Standard Deviation 0.437
|
—
|
—
|
—
|
|
Terminal Elimination Half-life (T1/2) of INC280 in the Dose-Determining Part
Cycle 1 Day 15
|
4.98 hours
Standard Deviation 2.00
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 30 minutes and 1, 2, 4, 6 and 8 hours after morning dose and 12 hours after evening dose on Cycle 1 Day 1 and Cycle 1 Day 15. The duration of one cycle was 21 days.Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure. PAS consists of all patients who provided an evaluable PK profile. A profile is considered evaluable if all the following conditions are satisfied: patient received at least one dose of the planned treatments, patient provided at least one primary PK parameter and patient did not vomit within 4 hours after the dosing of INC280. Full PK blood samples were not collected in the Dose-Expansion Part
PK parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods. Accumulation ratio of drug exposure was calculated as AUC0-12h on Cycle 1 Day 15 divided by AUC0-12h on Cycle 1 Day 1.
Outcome measures
| Measure |
Dose Determining
n=5 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
Accumulation Ratio (Racc) of INC280 in the Dose-Determining Part
|
1.56 ratio
Standard Deviation 0.275
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: On-treatment: Up to approximately 8 years and 2 months. Survival follow-up: Up to approximately 8 years and 2 months.Population: Safety Set: All patients who received at least one dose of INC280. Patients were analyzed according to the treatment they actually received.
On-treatment deaths were collected from start of treatment to 30 days after last dose. Survival follow-up deaths were collected from day 31 after last dose of study treatment until end of study. All deaths refer to the sum of on-treatment deaths plus survival follow-up deaths.
Outcome measures
| Measure |
Dose Determining
n=9 Participants
Patients enrolled in the Dose Determining part of the study
|
Dose Expansion: c-MET High
n=27 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET High
|
Dose Expansion: c-MET Low
n=2 Participants
Patients enrolled in the Dose Expansion part of the study with c-MET Low
|
Dose Expansion: All Patients
Patients enrolled in the Dose Expansion part of the study (c-MET High and c-MET Low)
|
|---|---|---|---|---|
|
All-Collected Deaths
On-treatment deaths
|
1 participants
|
5 participants
|
1 participants
|
—
|
|
All-Collected Deaths
Survival follow-up deaths
|
8 participants
|
17 participants
|
1 participants
|
—
|
|
All-Collected Deaths
All deaths
|
9 participants
|
22 participants
|
2 participants
|
—
|
Adverse Events
CINC280 300 mg BID Capsule - On-treatment
Serious events: 6 serious events
Other events: 9 other events
Deaths: 1 deaths
CINC280 600 mg BID Capsule - On-treatment
Serious events: 13 serious events
Other events: 27 other events
Deaths: 5 deaths
CINC280 400 mg BID Tablet - On-treatment
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
CINC280 300 mg BID Capsule - Survival Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
CINC280 600 mg BID Capsule - Survival Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 17 deaths
CINC280 400 mg BID Tablet - Survival Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CINC280 300 mg BID Capsule - On-treatment
n=9 participants at risk
AEs collected during on-treatment period (up to 30 days after last dose).
|
CINC280 600 mg BID Capsule - On-treatment
n=27 participants at risk
AEs collected during on-treatment period (up to 30 days after last dose).
|
CINC280 400 mg BID Tablet - On-treatment
n=2 participants at risk
AEs collected during on-treatment period (up to 30 days after last dose).
|
CINC280 300 mg BID Capsule - Survival Follow-up
Deaths collected in the survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period.
|
CINC280 600 mg BID Capsule - Survival Follow-up
Deaths collected in the survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period.
|
CINC280 400 mg BID Tablet - Survival Follow-up
Deaths collected in the survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Varices oesophageal
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
General disorders
General physical health deterioration
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Infections and infestations
Septic shock
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Vascular disorders
Hypovolaemic shock
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
Other adverse events
| Measure |
CINC280 300 mg BID Capsule - On-treatment
n=9 participants at risk
AEs collected during on-treatment period (up to 30 days after last dose).
|
CINC280 600 mg BID Capsule - On-treatment
n=27 participants at risk
AEs collected during on-treatment period (up to 30 days after last dose).
|
CINC280 400 mg BID Tablet - On-treatment
n=2 participants at risk
AEs collected during on-treatment period (up to 30 days after last dose).
|
CINC280 300 mg BID Capsule - Survival Follow-up
Deaths collected in the survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period.
|
CINC280 600 mg BID Capsule - Survival Follow-up
Deaths collected in the survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period.
|
CINC280 400 mg BID Tablet - Survival Follow-up
Deaths collected in the survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
3/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
22.2%
6/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
14.8%
4/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
11.1%
3/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Eye disorders
Visual field defect
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
2/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
22.2%
2/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Ascites
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
14.8%
4/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
22.2%
6/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
55.6%
5/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
29.6%
8/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Haematochezia
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Lip dry
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Mouth ulceration
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
6/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
33.3%
9/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
44.4%
4/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
33.3%
9/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
General disorders
Fatigue
|
33.3%
3/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
22.2%
6/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
General disorders
Oedema peripheral
|
22.2%
2/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
14.8%
4/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
General disorders
Peripheral swelling
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
11.1%
3/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
18.5%
5/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
14.8%
4/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Infections and infestations
Bronchitis
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Infections and infestations
Oral candidiasis
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
25.9%
7/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Amylase increased
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
11.1%
3/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
44.4%
12/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Blood bilirubin increased
|
22.2%
2/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
25.9%
7/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Blood cholesterol increased
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Blood creatinine increased
|
33.3%
3/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
25.9%
7/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Hepatitis B DNA increased
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Lipase increased
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
14.8%
4/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Weight decreased
|
22.2%
2/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Investigations
Weight increased
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
3/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
33.3%
9/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Metabolism and nutrition disorders
Dehydration
|
22.2%
2/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
22.2%
2/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
22.2%
2/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
25.9%
7/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
11.1%
3/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
11.1%
3/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Nervous system disorders
Syncope
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
18.5%
5/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
50.0%
1/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
7.4%
2/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
3.7%
1/27 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
0.00%
0/2 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
—
0/0 • Adverse events and deaths in the on-treatment period were collected from first dose of study treatment to 30 days after last dose, up to approximately 8 years and 2 months. Deaths were collected in the survival follow-up from day 31 after last dose of study treatment until the end of the study, up to approximately 8 years and 2 months. These are not considered AEs.
Patients were analyzed according to the treatment they actually received (Safety Set). Deaths in the survival follow-up are not considered Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER