Trial Outcomes & Findings for Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50% (NCT NCT04139317)
NCT ID: NCT04139317
Last Updated: 2024-10-09
Results Overview
PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. Tumor response was based on investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment, the start of a subsequent anti-neoplastic therapy (if any) or the date of sponsor's decision to discontinue capmatinib (applicable only to subjects on the combination arm). Due to the discontinuation of one of the investigational drugs (capmatinib) in all subjects in the combination arm, PFS was censored on the 21-Jan-2021 or the last adequate tumor assessment prior to that date for the capmatinib plus pembrolizumab arm. PFS was analyzed using Kaplan-Meier estimates.
TERMINATED
PHASE2
76 participants
Up to 1.3 years
2024-10-09
Participant Flow
Participants took part in 36 investigative sites in 16 countries.
The screening period began once patients had signed the study informed consent. Screening evaluations were performed within 28 days prior to the first dose of study treatment. After screening, the treatment period started on Cycle 1 Day 1.
Participant milestones
| Measure |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
25
|
|
Overall Study
Entered Post-treatment Follow-up
|
38
|
20
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
41
|
18
|
Reasons for withdrawal
| Measure |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
2
|
|
Overall Study
Death
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Progressive Disease
|
19
|
9
|
|
Overall Study
Subject Decision
|
2
|
2
|
Baseline Characteristics
Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%
Baseline characteristics by cohort
| Measure |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=51 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
n=25 Participants
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 7.59 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 8.80 • n=7 Participants
|
65.4 years
STANDARD_DEVIATION 8.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
22 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1.3 yearsPopulation: All patients to whom study treatment had been assigned by randomization.
PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. Tumor response was based on investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment, the start of a subsequent anti-neoplastic therapy (if any) or the date of sponsor's decision to discontinue capmatinib (applicable only to subjects on the combination arm). Due to the discontinuation of one of the investigational drugs (capmatinib) in all subjects in the combination arm, PFS was censored on the 21-Jan-2021 or the last adequate tumor assessment prior to that date for the capmatinib plus pembrolizumab arm. PFS was analyzed using Kaplan-Meier estimates.
Outcome measures
| Measure |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=51 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
n=25 Participants
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Progression-Free Survival (PFS) by Investigator Assessment as Per RECIST 1.1
|
5.2 months
Interval 2.0 to
Not estimable due to insufficient number of participants with events.
|
5.1 months
Interval 2.6 to
Not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 1.3 yearsPopulation: All patients to whom study treatment had been assigned by randomization.
Tumor response was based on local investigator assessment as 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 the capmatinib plus pembrolizumab arm, 21-Jan-2021 or any last adequate tumor assessment prior to that date was considered as the end of evaluation period for BOR. 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 |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=51 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
n=25 Participants
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Overall Response Rate (ORR) by Investigator Assessment as Per RECIST 1.1
|
9.8 Percentage of participants
Interval 3.3 to 21.4
|
40.0 Percentage of participants
Interval 21.1 to 61.3
|
SECONDARY outcome
Timeframe: Up to 1.3 yearsPopulation: All patients to whom study treatment had been assigned by randomization.
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), Stable Disease (SD), and non-CR/non-progressive disease (for subjects without target lesions). For the capmatinib plus pembrolizumab arm, 21-Jan-2021 or any last adequate tumor assessment prior to that date was considered as the end of evaluation period for BOR. 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 |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=51 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
n=25 Participants
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Disease Control Rate (DCR) by Investigator Assessment as Per RECIST 1.1
|
37.3 percentage of participants
Interval 24.1 to 51.9
|
60.0 percentage of participants
Interval 38.7 to 78.9
|
SECONDARY outcome
Timeframe: Up to 1.3 yearsPopulation: All patients to whom study treatment had been assigned by randomization.
TTR is defined as the time from the date of randomization to the first documented response of either complete response or partial response, which must be subsequently confirmed (although initial date of response is used, not date of confirmation). TTR was analyzed using the Kaplan-Meier method as defined in the statistical analysis plan.
Outcome measures
| Measure |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=51 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
n=25 Participants
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Time to Response (TTR) by Investigator Assessment as Per RECIST 1.1
|
NA months
Not estimable due to insufficient number of participants with events.
|
NA months
Not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 1.3 yearsPopulation: All patients to whom study treatment had been assigned by randomization and for whom best overall response was CR or PR as per RECIST v1.1 based on local investigator assessment.
DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment of overall lesion response according to RECIST v1.1. DOR is defined as the time from the date of first documented response (confirmed CR or confirmed PR) to the date of first documented disease progression or death due to any cause. If a patient not had an event, duration was censored at the date of last adequate tumor assessment before the start of a new anticancer therapy, if any. DOR was analyzed using the Kaplan-Meier method as defined in the statistical analysis plan.
Outcome measures
| Measure |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=5 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
n=10 Participants
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Duration of Response (DOR) by Investigator Assessment as Per RECIST 1.1
|
NA months
Not estimable due to insufficient number of participants with events.
|
NA months
Not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 2.1 yearsPopulation: All patients to whom study treatment had been assigned by randomization.
OS is defined as the time from the date of randomization to the date of death due to any cause. The requirement for survival follow-up period was removed following the discontinuation of one of the investigational drugs (capmatinib) in all subjects in the combination arm and the implementation of Protocol Amendment 03. OS was analyzed using the Kaplan-Meier method as defined in the statistical analysis plan.
Outcome measures
| Measure |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=51 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
n=25 Participants
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Not estimable due to insufficient number of participants with events.
|
NA months
Not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From first dose of study treatment to 30 days after last dose, up to 2.1 yearsPopulation: All patients to whom study treatment had been assigned by randomization. Patients are analyzed according to the treatment they were randomized to.
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 |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=51 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
n=25 Participants
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
49 Participants
|
25 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related AEs
|
45 Participants
|
18 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
31 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related SAEs
|
18 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs leading to discontinuation
|
18 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related AEs leading to discontinuation
|
17 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs leading to dose reduction/interruption
|
34 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related AEs leading to dose reduction/interruption
|
24 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days.Population: Patients in the capmatinib pharmacokinetic analysis set (INC-PAS) with an available value for the outcome measure. INC-PAS consists of all patients who provided at least one blood sample with measurable capmatinib PK data.
Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.
Outcome measures
| Measure |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=25 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Capmatinib
|
2730 ng/mL
Geometric Coefficient of Variation 155.9
|
—
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days.Population: Patients in the capmatinib pharmacokinetic analysis set (INC-PAS) with an available value for the outcome measure. INC-PAS consists of all patients who provided at least one blood sample with measurable capmatinib PK data.
PK parameters were calculated based on capmatinib 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 |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=25 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Capmatinib
|
1.33 hours
Interval 0.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days.Population: Patients in the capmatinib pharmacokinetic analysis set (INC-PAS) with an available value for the outcome measure. INC-PAS consists of all patients who provided at least one blood sample with measurable capmatinib PK data.
PK parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.
Outcome measures
| Measure |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=25 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Capmatinib
|
4210 hr*ng/mL
Geometric Coefficient of Variation 232.8
|
—
|
SECONDARY outcome
Timeframe: pre-dose on Cycle 2 Day 1, Cycle 3 Day 1, Cycle 6 Day 1 and Cycle 12 Day 1. The duration of one cycle was 21 days.Population: Patients in the pembrolizumab pharmacokinetic analysis set (Pembro-PAS) with an available value for the outcome measure at each timepoint. Pembro-PAS consists of all patients who provided at least one blood sample with measurable pembrolizumab PK data.
PK parameters were calculated based on pembrolizumab serum concentrations by using non-compartmental methods. Ctrough is defined as the concentration reached immediately before the next dose is administered. All drug concentrations below the lower limit of quantification were treated as zero for the calculation of PK parameters.
Outcome measures
| Measure |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=32 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
n=18 Participants
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Trough Serum Concentration (Ctrough) of Pembrolizumab
Cycle 2 Day 1
|
11.8 µg/mL
Geometric Coefficient of Variation 37.5
|
10.6 µg/mL
Geometric Coefficient of Variation 34.8
|
|
Trough Serum Concentration (Ctrough) of Pembrolizumab
Cycle 3 Day 1
|
18.9 µg/mL
Geometric Coefficient of Variation 51.9
|
18.2 µg/mL
Geometric Coefficient of Variation 32.3
|
|
Trough Serum Concentration (Ctrough) of Pembrolizumab
Cycle 6 Day 1
|
27.6 µg/mL
Geometric Coefficient of Variation 66.5
|
36.8 µg/mL
Geometric Coefficient of Variation 26.0
|
|
Trough Serum Concentration (Ctrough) of Pembrolizumab
Cycle 12 Day 1
|
—
|
49.7 µg/mL
Geometric Coefficient of Variation 10.0
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), up to 8 monthsPopulation: All patients to whom study treatment had been assigned by randomization and who had a determinant baseline IG sample and at least one determinant post-baseline IG sample. A determinant sample is neither ADA-inconclusive nor unevaluable.
Immunogenicity (IG) was evaluated in serum samples. The assay to quantify and assess the IG was a validated homogeneous enzyme-linked immunosorbent assay (ELISA). * ADA-negative at baseline: ADA-negative sample at baseline * ADA-positive at baseline: ADA-positive sample at baseline * ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline determinant sample, all of which are ADA-negative samples * ADA-positive post-baseline: patient with at least 1 ADA-positive sample post baseline
Outcome measures
| Measure |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=42 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
n=20 Participants
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
Number of Participants With Anti-pembrolizumab Antibodies
ADA-negative at baseline
|
37 Participants
|
18 Participants
|
|
Number of Participants With Anti-pembrolizumab Antibodies
ADA-positive at baseline
|
5 Participants
|
2 Participants
|
|
Number of Participants With Anti-pembrolizumab Antibodies
ADA-negative post-baseline
|
36 Participants
|
18 Participants
|
|
Number of Participants With Anti-pembrolizumab Antibodies
ADA-positive post-baseline
|
6 Participants
|
2 Participants
|
POST_HOC outcome
Timeframe: On-treatment: Up to 2.1 years after start of treatment. Post-treatment survival follow-up: Up to 1.3 years after start of treatment.Population: All patients to whom study treatment had been assigned by randomization. Patients are analyzed according to the treatment they were randomized to.
On-treatment deaths were collected from start of treatment to 30 days after last dose. Post-treatment survival follow-up deaths were collected from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03). All deaths refer to the sum of on-treatment deaths plus post-treatment survival follow-up deaths.
Outcome measures
| Measure |
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
n=51 Participants
Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
Pembrolizumab 200mg Q3W
n=25 Participants
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
|
|---|---|---|
|
All-Collected Deaths
On-treatment deaths
|
10 participants
|
3 participants
|
|
All-Collected Deaths
Post-treatment survival follow-up deaths
|
6 participants
|
5 participants
|
|
All-Collected Deaths
All deaths
|
16 participants
|
8 participants
|
Adverse Events
Capmatinib + Pembrolizumab - On-treatment
Pembrolizumab After Combination Treatment - On-treatment
Pembrolizumab - On-treatment
Capmatinib + Pembrolizumab - Post-treatment Survival Follow-up
Pembrolizumab - Post-treatment Survival Follow-up
Serious adverse events
| Measure |
Capmatinib + Pembrolizumab - On-treatment
n=51 participants at risk
Capmatinib 400 mg BID in combination with pembrolizumab 200 mg Q3W. AEs collected during on-treatment period (up to 30 days after last dose).
|
Pembrolizumab After Combination Treatment - On-treatment
n=51 participants at risk
Pembrolizumab single agent 200 mg Q3W after discontinuing capmatinib. AEs collected during on-treatment period (up to 30 days after last dose).
|
Pembrolizumab - On-treatment
n=25 participants at risk
Pembrolizumab single agent 200 mg Q3W from study start. AEs collected during on-treatment period (up to 30 days after last dose).
|
Capmatinib + Pembrolizumab - Post-treatment Survival Follow-up
Capmatinib 400 mg BID in combination with pembrolizumab 200 mg Q3W. Deaths collected in the post-treatment follow-up period (starting from day 31 after last dose). No AEs were collected during this period.
|
Pembrolizumab - Post-treatment Survival Follow-up
Pembrolizumab single agent 200 mg Q3W from study start. Deaths collected in the post-treatment follow-up period (starting from day 31 after last dose). No AEs were collected during this period.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Cardiac failure
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Disease progression
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
General physical health deterioration
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Pyrexia
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Immune system disorders
Hypersensitivity
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Bronchitis
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Encephalitis
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Meningitis listeria
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Myelitis
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Pneumonia
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Sepsis
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Septic shock
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Transaminases increased
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Brain oedema
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Hydrocephalus
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Seizure
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Vascular disorders
Hypotension
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
Other adverse events
| Measure |
Capmatinib + Pembrolizumab - On-treatment
n=51 participants at risk
Capmatinib 400 mg BID in combination with pembrolizumab 200 mg Q3W. AEs collected during on-treatment period (up to 30 days after last dose).
|
Pembrolizumab After Combination Treatment - On-treatment
n=51 participants at risk
Pembrolizumab single agent 200 mg Q3W after discontinuing capmatinib. AEs collected during on-treatment period (up to 30 days after last dose).
|
Pembrolizumab - On-treatment
n=25 participants at risk
Pembrolizumab single agent 200 mg Q3W from study start. AEs collected during on-treatment period (up to 30 days after last dose).
|
Capmatinib + Pembrolizumab - Post-treatment Survival Follow-up
Capmatinib 400 mg BID in combination with pembrolizumab 200 mg Q3W. Deaths collected in the post-treatment follow-up period (starting from day 31 after last dose). No AEs were collected during this period.
|
Pembrolizumab - Post-treatment Survival Follow-up
Pembrolizumab single agent 200 mg Q3W from study start. Deaths collected in the post-treatment follow-up period (starting from day 31 after last dose). No AEs were collected during this period.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.8%
4/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Endocrine disorders
Hypothyroidism
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
11.8%
6/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
9.8%
5/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
13.7%
7/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
16.0%
4/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.7%
8/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
7.8%
4/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
24.0%
6/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
25.5%
13/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
27.5%
14/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Asthenia
|
7.8%
4/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Chest pain
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Chills
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Fatigue
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Oedema peripheral
|
27.5%
14/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
11.8%
6/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Pyrexia
|
17.6%
9/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
COVID-19
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Alanine aminotransferase increased
|
21.6%
11/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
7.8%
4/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Amylase increased
|
7.8%
4/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Aspartate aminotransferase increased
|
21.6%
11/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.8%
5/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood bilirubin increased
|
11.8%
6/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood creatinine increased
|
13.7%
7/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.8%
4/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Lipase increased
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
SARS-CoV-2 test negative
|
7.8%
4/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.8%
5/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.8%
6/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.8%
5/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
9.8%
5/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
24.0%
6/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
4/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
16.0%
4/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Psychiatric disorders
Insomnia
|
7.8%
4/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
16.0%
4/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
16.0%
4/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.8%
5/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
9.8%
5/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
5/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
13.7%
7/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
32.0%
8/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.8%
5/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
9.8%
5/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Vascular disorders
Hypertension
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
24.0%
6/25 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
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