Trial Outcomes & Findings for Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (NCT NCT03737994)
NCT ID: NCT03737994
Last Updated: 2025-08-13
Results Overview
ORR= number of subjects with best overall response (BOR) of complete or partial response (CR, PR) divided by number of evaluable subjects. BOR= best response recorded from start of treatment to first progression (PD)/new anticancer therapy, otherwise last follow-up. * CR: disappearance of target and non-target lesions; no new lesions; pathological lymph nodes \< 10mm. * PR: 30% decrease in target lesions; non-target lesions not progressed or not evaluated; no new lesions. * PD: 20% increase of target lesions and/or new lesion(s). ORR was to be compared using Fisher's exact test within each ALK inhibitor treatment arm (each mutation vs. no mutation) and also within the subset of subjects with no mutation comparing each experimental arm vs. pemetrexed. Due to early accrual closure (few subjects), only the number of subjects with BOR of CR or PR are provided, by mutation, no statistical testing. Analysis was to occur after each patient was potentially followed ≥ 24 weeks.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Baseline to 24 weeks
Results posted on
2025-08-13
Participant Flow
Tissue and blood submissions were required after first step registration, before second step registration (treatment assignment). Of 16 participants screened, 10 were assigned to treatment.
Participant milestones
| Measure |
Lorlatinib
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, compound mutation\*, or no mutations, can be assigned to receive lorlatinib. \*Compound mutation = two or more resistance mutation excluding those with L1198F or L1189F/MET amplification = L1198F mutation alone or in combination, or no anaplastic lymphoma kinase (ALK) mutation but any MET amplification.
Lorlatinib: 100 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
LDK378 (Ceritinib)
Participants with I1171, L1196 (including L1196M), or V1180 mutations, or no having no ALK-resistance mutations or MET amplifications, can be assigned to receive ceritinib
Ceritinib: 450 mg orally once a day with food. Treatment continues until disease progression or unacceptable toxicity.
|
Alectinib
Participants with C1156Y, L1196 (including L1196M), or F1174 mutations, or no having no ALK-resistance mutations or MET amplifications, can be assigned to receive Alectinib.
Alectinib: 600 mg orally twice daily with food. Treatment continues until disease progression or unacceptable toxicity.
|
Brigatinib
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive brigatinib.
Brigatinib: 90 mg orally once a day (with or without food) for the first 7 days; if tolerated, with no respiratory symptoms, increase the dose to 180 mg once daily. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Crizotinib
Participants with ALK L1198F (alone/ in combination with another ALK mutation) or mesenchymal-to-epithelial transition (MET) amplification can be assigned to receive crizotinib
Crizotinib: 250 mg orally twice daily with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Pemetrexed +/- Cisplatin or Carboplatin
Participants with no ALK-resistance mutations or MET amplifications can be assigned to receive pemetrexed, which optionally can be combined with cisplatin or carboplatin.
Carboplatin: Carboplatin is optional. Dosing of area under the curve (AUC) = 5 once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed) intravenously, prepared and administered per institution policy. Continues for 4-6 cycles.
Cisplatin: Cisplatin is optional. 75 mg/m\^2 intravenously once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed), prepared and administered per institution policy.
Pemetrexed: Pemetrexed may be given alone or with either cisplatin or carboplatin. Pemetrexed 500 mg/m2 administered intravenously on Day 1 of a 21 day cycle, optionally with cisplatin or carboplatin for 4-6 cycles. Then pemetrexed (as a single agent) continues until progression or significant toxicity.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
0
|
2
|
3
|
0
|
1
|
|
Overall Study
Disease Assessment Population
|
3
|
1
|
0
|
2
|
2
|
0
|
0
|
|
Overall Study
Survival Population
|
3
|
1
|
0
|
2
|
3
|
0
|
0
|
|
Overall Study
Adverse Event Population
|
3
|
1
|
0
|
2
|
3
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
1
|
0
|
2
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Lorlatinib
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, compound mutation\*, or no mutations, can be assigned to receive lorlatinib. \*Compound mutation = two or more resistance mutation excluding those with L1198F or L1189F/MET amplification = L1198F mutation alone or in combination, or no anaplastic lymphoma kinase (ALK) mutation but any MET amplification.
Lorlatinib: 100 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
LDK378 (Ceritinib)
Participants with I1171, L1196 (including L1196M), or V1180 mutations, or no having no ALK-resistance mutations or MET amplifications, can be assigned to receive ceritinib
Ceritinib: 450 mg orally once a day with food. Treatment continues until disease progression or unacceptable toxicity.
|
Alectinib
Participants with C1156Y, L1196 (including L1196M), or F1174 mutations, or no having no ALK-resistance mutations or MET amplifications, can be assigned to receive Alectinib.
Alectinib: 600 mg orally twice daily with food. Treatment continues until disease progression or unacceptable toxicity.
|
Brigatinib
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive brigatinib.
Brigatinib: 90 mg orally once a day (with or without food) for the first 7 days; if tolerated, with no respiratory symptoms, increase the dose to 180 mg once daily. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Crizotinib
Participants with ALK L1198F (alone/ in combination with another ALK mutation) or mesenchymal-to-epithelial transition (MET) amplification can be assigned to receive crizotinib
Crizotinib: 250 mg orally twice daily with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Pemetrexed +/- Cisplatin or Carboplatin
Participants with no ALK-resistance mutations or MET amplifications can be assigned to receive pemetrexed, which optionally can be combined with cisplatin or carboplatin.
Carboplatin: Carboplatin is optional. Dosing of area under the curve (AUC) = 5 once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed) intravenously, prepared and administered per institution policy. Continues for 4-6 cycles.
Cisplatin: Cisplatin is optional. 75 mg/m\^2 intravenously once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed), prepared and administered per institution policy.
Pemetrexed: Pemetrexed may be given alone or with either cisplatin or carboplatin. Pemetrexed 500 mg/m2 administered intravenously on Day 1 of a 21 day cycle, optionally with cisplatin or carboplatin for 4-6 cycles. Then pemetrexed (as a single agent) continues until progression or significant toxicity.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Lorlatinib
n=3 Participants
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, compound mutation\*, or no mutations, can be assigned to receive lorlatinib. \*Compound mutation = two or more resistance mutation excluding those with L1198F or L1189F/MET amplification = L1198F mutation alone or in combination, or no ALK mutation but any MET amplification.
Lorlatinib: 100 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
LDK378 (Ceritinib)
n=1 Participants
Participants with I1171, L1196 (including L1196M), or V1180 mutations, or no having no ALK-resistance mutations or MET amplifications, can be assigned to receive ceritinib
Ceritinib: 450 mg orally once a day with food. Treatment continues until disease progression or unacceptable toxicity.
|
Brigatinib
n=2 Participants
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive brigatinib.
Brigatinib: 90 mg orally once a day (with or without food) for the first 7 days; if tolerated, with no respiratory symptoms, increase the dose to 180 mg once daily. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
n=3 Participants
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Pemetrexed +/- Cisplatin or Carboplatin
n=1 Participants
Participants with no ALK-resistance mutations or MET amplifications can be assigned to receive pemetrexed, which optionally can be combined with cisplatin or carboplatin.
Carboplatin: Carboplatin is optional. Dosing of area under the curve (AUC) = 5 once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed) intravenously, prepared and administered per institution policy. Continues for 4-6 cycles.
Cisplatin: Cisplatin is optional. 75 mg/m\^2 intravenously once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed), prepared and administered per institution policy.
Pemetrexed: Pemetrexed may be given alone or with either cisplatin or carboplatin. Pemetrexed 500 mg/m2 administered intravenously on Day 1 of a 21 day cycle, optionally with cisplatin or carboplatin for 4-6 cycles. Then pemetrexed (as a single agent) continues until progression or significant toxicity.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
<= 49 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Age, Customized
50-59 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Age, Customized
60-69 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Age, Customized
>= 70 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Mutation
I1171
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Mutation
No ALK-resistance mutation / MET amplification
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Has CNS metastases
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksPopulation: Eligible participants who started protocol treatment and had post-baseline disease assessment. Treatment arms with no evaluable participants are not shown.
ORR= number of subjects with best overall response (BOR) of complete or partial response (CR, PR) divided by number of evaluable subjects. BOR= best response recorded from start of treatment to first progression (PD)/new anticancer therapy, otherwise last follow-up. * CR: disappearance of target and non-target lesions; no new lesions; pathological lymph nodes \< 10mm. * PR: 30% decrease in target lesions; non-target lesions not progressed or not evaluated; no new lesions. * PD: 20% increase of target lesions and/or new lesion(s). ORR was to be compared using Fisher's exact test within each ALK inhibitor treatment arm (each mutation vs. no mutation) and also within the subset of subjects with no mutation comparing each experimental arm vs. pemetrexed. Due to early accrual closure (few subjects), only the number of subjects with BOR of CR or PR are provided, by mutation, no statistical testing. Analysis was to occur after each patient was potentially followed ≥ 24 weeks.
Outcome measures
| Measure |
Lorlatinib
n=3 Participants
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, compound mutation\*, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive lorlatinib. \*Compound mutation = two or more resistance mutation excluding those with L1198F or L1189F/MET amplification = L1198F mutation alone or in combination, or no ALK mutation but any MET amplification.
Lorlatinib: 100 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
LDK378 (Ceritinib)
n=1 Participants
Participants with I1171, L1196 (including L1196M), or V1180 mutations, or no having no ALK-resistance mutations or MET amplifications, can be assigned to receive ceritinib.
Ceritinib: 450 mg orally once a day with food. Treatment continues until disease progression or unacceptable toxicity.
|
Brigatinib
n=2 Participants
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive brigatinib.
Brigatinib: 90 mg orally once a day (with or without food) for the first 7 days; if tolerated, with no respiratory symptoms, increase the dose to 180 mg once daily. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
n=2 Participants
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Crizotinib
Participants with ALK L1198F (alone/ in combination with another ALK mutation) or mesenchymal-to-epithelial transition (MET) amplification can be assigned to receive crizotinib Crizotinib: 250 mg orally twice daily with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Pemetrexed +/- Cisplatin or Carboplatin
Participants with no ALK-resistance mutations or MET amplifications can be assigned to receive pemetrexed, which optionally can be combined with cisplatin or carboplatin.
Carboplatin: Carboplatin is optional. Dosing of area under the curve (AUC) = 5 once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed) intravenously, prepared and administered per institution policy. Continues for 4-6 cycles.
Cisplatin: Cisplatin is optional. 75 mg/m\^2 intravenously once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed), prepared and administered per institution policy.
Pemetrexed: Pemetrexed may be given alone or with either cisplatin or carboplatin. Pemetrexed 500 mg/m2 administered intravenously on Day 1 of a 21 day cycle, optionally with cisplatin or carboplatin for 4-6 cycles. Then pemetrexed (as a single agent) continues until progression or significant toxicity.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria
Mutation = I1171: BOR of CR or PR
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria
Mutation = None: BOR of CR or PR
|
2 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to the date of the first disease progression / progressive disease, death, or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.Population: Eligible participants who started protocol treatment and had post-baseline disease assessment. Treatment arms with no evaluable participants are not shown.
Progression-free survival time is defined as the time from second step registration to the date of the first disease progression / progressive disease (PD), death, or last known follow-up (censored). Progressive disease is defined as a 20% increase of target lesions and/or new lesion(s). Percentage of participants progression-free at a given time (PFS) was to be estimated by the Kaplan-Meier method. Median PFS and PFS at specific time points was to be reported, with 95% confidence intervals, for each mutation (or no mutation)/regimen combination. Due to early accrual closure resulting in few participants, only the number of participants who progressed or died, by mutation, with no statistical testing.
Outcome measures
| Measure |
Lorlatinib
n=3 Participants
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, compound mutation\*, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive lorlatinib. \*Compound mutation = two or more resistance mutation excluding those with L1198F or L1189F/MET amplification = L1198F mutation alone or in combination, or no ALK mutation but any MET amplification.
Lorlatinib: 100 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
LDK378 (Ceritinib)
n=1 Participants
Participants with I1171, L1196 (including L1196M), or V1180 mutations, or no having no ALK-resistance mutations or MET amplifications, can be assigned to receive ceritinib.
Ceritinib: 450 mg orally once a day with food. Treatment continues until disease progression or unacceptable toxicity.
|
Brigatinib
n=2 Participants
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive brigatinib.
Brigatinib: 90 mg orally once a day (with or without food) for the first 7 days; if tolerated, with no respiratory symptoms, increase the dose to 180 mg once daily. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
n=2 Participants
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Crizotinib
Participants with ALK L1198F (alone/ in combination with another ALK mutation) or mesenchymal-to-epithelial transition (MET) amplification can be assigned to receive crizotinib Crizotinib: 250 mg orally twice daily with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Pemetrexed +/- Cisplatin or Carboplatin
Participants with no ALK-resistance mutations or MET amplifications can be assigned to receive pemetrexed, which optionally can be combined with cisplatin or carboplatin.
Carboplatin: Carboplatin is optional. Dosing of area under the curve (AUC) = 5 once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed) intravenously, prepared and administered per institution policy. Continues for 4-6 cycles.
Cisplatin: Cisplatin is optional. 75 mg/m\^2 intravenously once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed), prepared and administered per institution policy.
Pemetrexed: Pemetrexed may be given alone or with either cisplatin or carboplatin. Pemetrexed 500 mg/m2 administered intravenously on Day 1 of a 21 day cycle, optionally with cisplatin or carboplatin for 4-6 cycles. Then pemetrexed (as a single agent) continues until progression or significant toxicity.
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria
Mutation = I1107: progression or death
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria
Mutation = none: progression or death
|
1 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to the date of the first disease progression / progressive disease, death, or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.Population: Eligible participants who started protocol treatment and had complete or partial response. Treatment arms with no evaluable participants are not shown.
Duration of overall response (DOR) is defined as the time from the first occurrence of a documented BOR of CR or PR to the first date of recorded disease progression (PD) or death from any cause (whichever occurs first). BOR is the best response recorded from the start of treatment to first progression (PD)/new anticancer therapy, otherwise last follow-up. * CR: disappearance of target and non-target lesions; no new lesions; pathological lymph nodes \< 10mm. * PR: 30% decrease in target lesions; non-target lesions not progressed or not evaluated; no new lesions. * PD: 20% increase of target lesions and/or new lesion(s). Median DOR was to be estimated, with 95% confidence intervals, for each mutation/regimen combination using the Kaplan-Meier method. Due to early accrual closure resulting in few subjects, only the mean and range DOR are provided, by mutation, and no statistical testing was done.
Outcome measures
| Measure |
Lorlatinib
n=3 Participants
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, compound mutation\*, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive lorlatinib. \*Compound mutation = two or more resistance mutation excluding those with L1198F or L1189F/MET amplification = L1198F mutation alone or in combination, or no ALK mutation but any MET amplification.
Lorlatinib: 100 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
LDK378 (Ceritinib)
n=1 Participants
Participants with I1171, L1196 (including L1196M), or V1180 mutations, or no having no ALK-resistance mutations or MET amplifications, can be assigned to receive ceritinib.
Ceritinib: 450 mg orally once a day with food. Treatment continues until disease progression or unacceptable toxicity.
|
Brigatinib
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive brigatinib.
Brigatinib: 90 mg orally once a day (with or without food) for the first 7 days; if tolerated, with no respiratory symptoms, increase the dose to 180 mg once daily. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Crizotinib
Participants with ALK L1198F (alone/ in combination with another ALK mutation) or mesenchymal-to-epithelial transition (MET) amplification can be assigned to receive crizotinib Crizotinib: 250 mg orally twice daily with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Pemetrexed +/- Cisplatin or Carboplatin
Participants with no ALK-resistance mutations or MET amplifications can be assigned to receive pemetrexed, which optionally can be combined with cisplatin or carboplatin.
Carboplatin: Carboplatin is optional. Dosing of area under the curve (AUC) = 5 once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed) intravenously, prepared and administered per institution policy. Continues for 4-6 cycles.
Cisplatin: Cisplatin is optional. 75 mg/m\^2 intravenously once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed), prepared and administered per institution policy.
Pemetrexed: Pemetrexed may be given alone or with either cisplatin or carboplatin. Pemetrexed 500 mg/m2 administered intravenously on Day 1 of a 21 day cycle, optionally with cisplatin or carboplatin for 4-6 cycles. Then pemetrexed (as a single agent) continues until progression or significant toxicity.
|
|---|---|---|---|---|---|---|---|
|
Duration of Overall Response, Per Investigator Assessment Using RECIST v1.1
Mutation = I1171
|
27.9 months
Interval 27.9 to 27.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Overall Response, Per Investigator Assessment Using RECIST v1.1
Mutation = None
|
19.2 months
Interval 9.4 to 29.1
|
3.5 months
Interval 3.5 to 3.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to the date of death or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.Population: Eligible participants who started protocol treatment, with post-baseline survival status. Treatment arms with no evaluable participants are not shown.
Survival time is defined as the time from second step registration to the date of death, or last known follow-up (censored). Percentage of participants alive at a given time (OS) was to be estimated by the Kaplan-Meier method. Median OS and OS at specific time points was to be reported, with 95% confidence intervals, for each mutation/regimen combination. Due to early accrual closure resulting in few patients, only the number of participants who died are provided, by mutation, and no statistical testing was done.
Outcome measures
| Measure |
Lorlatinib
n=3 Participants
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, compound mutation\*, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive lorlatinib. \*Compound mutation = two or more resistance mutation excluding those with L1198F or L1189F/MET amplification = L1198F mutation alone or in combination, or no ALK mutation but any MET amplification.
Lorlatinib: 100 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
LDK378 (Ceritinib)
n=1 Participants
Participants with I1171, L1196 (including L1196M), or V1180 mutations, or no having no ALK-resistance mutations or MET amplifications, can be assigned to receive ceritinib.
Ceritinib: 450 mg orally once a day with food. Treatment continues until disease progression or unacceptable toxicity.
|
Brigatinib
n=2 Participants
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive brigatinib.
Brigatinib: 90 mg orally once a day (with or without food) for the first 7 days; if tolerated, with no respiratory symptoms, increase the dose to 180 mg once daily. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
n=3 Participants
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Crizotinib
Participants with ALK L1198F (alone/ in combination with another ALK mutation) or mesenchymal-to-epithelial transition (MET) amplification can be assigned to receive crizotinib Crizotinib: 250 mg orally twice daily with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Pemetrexed +/- Cisplatin or Carboplatin
Participants with no ALK-resistance mutations or MET amplifications can be assigned to receive pemetrexed, which optionally can be combined with cisplatin or carboplatin.
Carboplatin: Carboplatin is optional. Dosing of area under the curve (AUC) = 5 once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed) intravenously, prepared and administered per institution policy. Continues for 4-6 cycles.
Cisplatin: Cisplatin is optional. 75 mg/m\^2 intravenously once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed), prepared and administered per institution policy.
Pemetrexed: Pemetrexed may be given alone or with either cisplatin or carboplatin. Pemetrexed 500 mg/m2 administered intravenously on Day 1 of a 21 day cycle, optionally with cisplatin or carboplatin for 4-6 cycles. Then pemetrexed (as a single agent) continues until progression or significant toxicity.
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
Mutation = I1171: deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Overall Survival (OS)
Mutation = None: deaths
|
0 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: No participants with baseline CNS metastasis had evaluable post-baseline CNS metastasis assessment.
Intracranial objective response rate (IORR) is defined as the number of participants with central nervous system (CNS) metastasis complete or partial response (CR, PR) divided by the number of evaluable participants with baseline CNS metastasis and no prior CNS radiation therapy. Participants who required additional treatment (for their non-cranial systemic disease) would be considered as non-responders (if they have not previously had an intracranial response). * CR: disappearance of target and non-target lesions; no new lesions; pathological lymph nodes \< 10mm. * PR: 30% decrease in target lesions; non-target lesions not progressed or not evaluated; no new lesions. IORR was to be estimated for each mutation/regimen combination, with the associated 95% confidence intervals (using Clapper-Pearson method). Due to early accrual closure resulting in few subjects, only the number of subjects with CR or PR are provided, by mutation, with no statistical testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.Population: Eligible participants who started protocol treatment, with adverse event data. Treatment arms with no evaluable participants are not shown.
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Outcome measures
| Measure |
Lorlatinib
n=3 Participants
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, compound mutation\*, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive lorlatinib. \*Compound mutation = two or more resistance mutation excluding those with L1198F or L1189F/MET amplification = L1198F mutation alone or in combination, or no ALK mutation but any MET amplification.
Lorlatinib: 100 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
LDK378 (Ceritinib)
n=1 Participants
Participants with I1171, L1196 (including L1196M), or V1180 mutations, or no having no ALK-resistance mutations or MET amplifications, can be assigned to receive ceritinib.
Ceritinib: 450 mg orally once a day with food. Treatment continues until disease progression or unacceptable toxicity.
|
Brigatinib
n=2 Participants
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, or having no ALK-resistance mutations or MET amplifications, can be assigned to receive brigatinib.
Brigatinib: 90 mg orally once a day (with or without food) for the first 7 days; if tolerated, with no respiratory symptoms, increase the dose to 180 mg once daily. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
n=3 Participants
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
Participants with L1196 (including L1196M) mutations or having no ALK-resistance mutations or MET amplifications can be assigned to receive ensartinib.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Crizotinib
Participants with ALK L1198F (alone/ in combination with another ALK mutation) or mesenchymal-to-epithelial transition (MET) amplification can be assigned to receive crizotinib Crizotinib: 250 mg orally twice daily with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Pemetrexed +/- Cisplatin or Carboplatin
Participants with no ALK-resistance mutations or MET amplifications can be assigned to receive pemetrexed, which optionally can be combined with cisplatin or carboplatin.
Carboplatin: Carboplatin is optional. Dosing of area under the curve (AUC) = 5 once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed) intravenously, prepared and administered per institution policy. Continues for 4-6 cycles.
Cisplatin: Cisplatin is optional. 75 mg/m\^2 intravenously once every 3 weeks (on Day 1 of a 21 day cycle with pemetrexed), prepared and administered per institution policy.
Pemetrexed: Pemetrexed may be given alone or with either cisplatin or carboplatin. Pemetrexed 500 mg/m2 administered intravenously on Day 1 of a 21 day cycle, optionally with cisplatin or carboplatin for 4-6 cycles. Then pemetrexed (as a single agent) continues until progression or significant toxicity.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants by Highest Grade Adverse Event Reported
Mutation = none · Grade 5
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants by Highest Grade Adverse Event Reported
Mutation = I1107 · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Highest Grade Adverse Event Reported
Mutation = I1107 · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Highest Grade Adverse Event Reported
Mutation = I1107 · Grade 3
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Highest Grade Adverse Event Reported
Mutation = I1107 · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Highest Grade Adverse Event Reported
Mutation = I1107 · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Highest Grade Adverse Event Reported
Mutation = none · Grade 1
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants by Highest Grade Adverse Event Reported
Mutation = none · Grade 2
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants by Highest Grade Adverse Event Reported
Mutation = none · Grade 3
|
2 Participants
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants by Highest Grade Adverse Event Reported
Mutation = none · Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: No assay data for analysis was received.
For each mutation, the agreement of the biopsy result (present, absent, unavailable) and the cfDNA result (present, absent, unavailable) would be assessed. Agreement of cfDNA and biopsy results will be considered separately for MET amplification and for the gene mutations. This outcome measure was to be contingent upon FDA approval of the outcome measure analysis plan, which was not pursued due to the early accrual closure.
Outcome measures
Outcome data not reported
Adverse Events
Lorlatinib (Mutations)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Lorlatinib (no Mutations)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
LDK378 (Ceritinib)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Brigatinib (Mutations)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Brigatinib (no Mutations)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Ensartinib
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Lorlatinib (Mutations)
n=1 participants at risk
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, or compound mutation\*. \*Compound mutation = two or more resistance mutation excluding those with L1198F or L1189F/MET amplification = L1198F mutation alone or in combination, or no ALK mutation but any MET amplification.
Lorlatinib: 100 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Lorlatinib (no Mutations)
n=2 participants at risk
Participants with no ALK-resistance mutations or MET amplifications.
Lorlatinib: 100 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
LDK378 (Ceritinib)
n=1 participants at risk
Participants with I1171, L1196 (including L1196M), or V1180 mutations.
Ceritinib: 450 mg orally once a day with food. Treatment continues until disease progression or unacceptable toxicity.
|
Brigatinib (Mutations)
n=1 participants at risk
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations.
Brigatinib: 90 mg orally once a day (with or without food) for the first 7 days; if tolerated, with no respiratory symptoms, increase the dose to 180 mg once daily. Treatment continues until disease progression or unacceptable toxicity.
|
Brigatinib (no Mutations)
n=1 participants at risk
Participants with no ALK-resistance mutations or MET amplifications.
Brigatinib: 90 mg orally once a day (with or without food) for the first 7 days; if tolerated, with no respiratory symptoms, increase the dose to 180 mg once daily. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
n=3 participants at risk
Participants with no ALK-resistance mutations or MET amplifications.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
Other adverse events
| Measure |
Lorlatinib (Mutations)
n=1 participants at risk
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations, or compound mutation\*. \*Compound mutation = two or more resistance mutation excluding those with L1198F or L1189F/MET amplification = L1198F mutation alone or in combination, or no ALK mutation but any MET amplification.
Lorlatinib: 100 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
Lorlatinib (no Mutations)
n=2 participants at risk
Participants with no ALK-resistance mutations or MET amplifications.
Lorlatinib: 100 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
LDK378 (Ceritinib)
n=1 participants at risk
Participants with I1171, L1196 (including L1196M), or V1180 mutations.
Ceritinib: 450 mg orally once a day with food. Treatment continues until disease progression or unacceptable toxicity.
|
Brigatinib (Mutations)
n=1 participants at risk
Participants with G1202 (including G1202del and G1202R), C1156Y, I1171, L1196 (including L1196M), V1180, or F1174 mutations.
Brigatinib: 90 mg orally once a day (with or without food) for the first 7 days; if tolerated, with no respiratory symptoms, increase the dose to 180 mg once daily. Treatment continues until disease progression or unacceptable toxicity.
|
Brigatinib (no Mutations)
n=1 participants at risk
Participants with no ALK-resistance mutations or MET amplifications.
Brigatinib: 90 mg orally once a day (with or without food) for the first 7 days; if tolerated, with no respiratory symptoms, increase the dose to 180 mg once daily. Treatment continues until disease progression or unacceptable toxicity.
|
Ensartinib
n=3 participants at risk
Participants with no ALK-resistance mutations or MET amplifications.
Ensartinib: 225 mg orally once a day with or without food. Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Eye disorders
Blurred vision
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
2/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
66.7%
2/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
66.7%
2/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
66.7%
2/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
General disorders
Edema limbs
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
66.7%
2/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
General disorders
Flu like symptoms
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
General disorders
Generalized edema
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
General disorders
Localized edema
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Infections and infestations
Papulopustular rash
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Investigations
Cholesterol high
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Investigations
Creatinine increased
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Investigations
Lipase increased
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Investigations
Serum amylase increased
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
2/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Nervous system disorders
Memory impairment
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Psychiatric disorders
Insomnia
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
66.7%
2/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
50.0%
1/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Vascular disorders
Hypertension
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
100.0%
1/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/2 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
0.00%
0/1 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
33.3%
1/3 • Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.
Note, treatment arms are reported by mutation / no mutation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior approval from the sponsor. In addition, PI's are required to abide by Collaborator's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER